Regulatory Open Forum

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time. 

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 9/7/2021 12:18:00 PM
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time. 

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Good day,

Well as someone that does not post anonymously it does not bother me if others do post anonymously.  Personally, I do not find there are so many controversial postings on RAPS forum as its not a place for strong debating platform or addressing current political topics.  While there may be differences of opinions on certain topics, e.g. risk analysis, responsibilities of regulatory person, nonconformity findings, EU regulatory *cough cough* haha, they do not seem to get "out of control".  I have seen in other forums where "forum wars" ensue (like Elsmar) as people do have strong opinions concerning different topics.  Here, I think people are mostly looking for help or advice, so posting anonymously is ok because just like many training classes which I teach, Q&A session: anyone have any questions?  Silence.  Then during the breaks, I get 20 questions from 20 different people :) usually too shy or don't want to feel like - hmm as a regulatory professional I should know this answer, but I really don't.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 07-Sep-2021 15:02
From: Ed Panek
Subject: Anonymous postings

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

To add my two cents worth with regards to WHY anonymous postings are created, I find one reason for this is that some might be embarrassed with asking questions that could be easily answered had US FDA's IT and database searches caught up with Big Data times as Richard alluded to during his presentations and thereafter with 'shy' inquirers.

The US FDA medical devices Guidance search site is woefully inadequate and  presents an abysmal search engine that searches not actual PDF Guidance content but only metadata.

I can find more search hits with a Google query than I can find in US FDA's site search for medical device guidance regarding "stents" for example.

Guidance Documents (Medical Devices and Radiation-Emitting Products)

U.S. Food and Drug Administration		remove preview
Guidance Documents (Medical Devices and Radiation-Emitting Products) What is guidance? Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. View this on U.S. Food and Drug Administration >

------------------------------
Ram Balani
CEO
FDASmart Inc.
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)
------------------------------

Original Message:
Sent: 08-Sep-2021 04:50
From: Richard Vincins
Subject: Anonymous postings

Good day,

Well as someone that does not post anonymously it does not bother me if others do post anonymously.  Personally, I do not find there are so many controversial postings on RAPS forum as its not a place for strong debating platform or addressing current political topics.  While there may be differences of opinions on certain topics, e.g. risk analysis, responsibilities of regulatory person, nonconformity findings, EU regulatory *cough cough* haha, they do not seem to get "out of control".  I have seen in other forums where "forum wars" ensue (like Elsmar) as people do have strong opinions concerning different topics.  Here, I think people are mostly looking for help or advice, so posting anonymously is ok because just like many training classes which I teach, Q&A session: anyone have any questions?  Silence.  Then during the breaks, I get 20 questions from 20 different people :) usually too shy or don't want to feel like - hmm as a regulatory professional I should know this answer, but I really don't.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Sep-2021 15:02
From: Ed Panek
Subject: Anonymous postings

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

All,

 I agree that the FDA search engine is woefully inadequate, and that it is often better to use another internet search engine to find what you are looking for.

------------------------------
James Bonds J.D.
Director Regulatory Affairs
Atlanta GA
United States
------------------------------

Original Message:
Sent: 08-Sep-2021 07:50
From: Ram Balani
Subject: Anonymous postings

To add my two cents worth with regards to WHY anonymous postings are created, I find one reason for this is that some might be embarrassed with asking questions that could be easily answered had US FDA's IT and database searches caught up with Big Data times as Richard alluded to during his presentations and thereafter with 'shy' inquirers.

The US FDA medical devices Guidance search site is woefully inadequate and  presents an abysmal search engine that searches not actual PDF Guidance content but only metadata.

I can find more search hits with a Google query than I can find in US FDA's site search for medical device guidance regarding "stents" for example.

Guidance Documents (Medical Devices and Radiation-Emitting Products)

U.S. Food and Drug Administration		remove preview
Guidance Documents (Medical Devices and Radiation-Emitting Products) What is guidance? Guidance documents are documents prepared for FDA staff, regulated industry, and the public that describe the agency's interpretation of or policy on a regulatory issue. View this on U.S. Food and Drug Administration >

------------------------------
Ram Balani
CEO
FDASmart Inc.
Amawalk , New York
rbalani@fdasmart.com
2019130558
https://tinyurl.com/2wkxp69y
on US FDA eSTAR for 510(K)

Original Message:
Sent: 08-Sep-2021 04:50
From: Richard Vincins
Subject: Anonymous postings

Good day,

Well as someone that does not post anonymously it does not bother me if others do post anonymously.  Personally, I do not find there are so many controversial postings on RAPS forum as its not a place for strong debating platform or addressing current political topics.  While there may be differences of opinions on certain topics, e.g. risk analysis, responsibilities of regulatory person, nonconformity findings, EU regulatory *cough cough* haha, they do not seem to get "out of control".  I have seen in other forums where "forum wars" ensue (like Elsmar) as people do have strong opinions concerning different topics.  Here, I think people are mostly looking for help or advice, so posting anonymously is ok because just like many training classes which I teach, Q&A session: anyone have any questions?  Silence.  Then during the breaks, I get 20 questions from 20 different people :) usually too shy or don't want to feel like - hmm as a regulatory professional I should know this answer, but I really don't.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Sep-2021 15:02
From: Ed Panek
Subject: Anonymous postings

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Hi Richard,

I am a moderator on Elsmar and we are struggling with anonymous postings and people using the anonymous tag to "jump into" a thread to act as a third opinion. A debate is going on there.
Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 08-Sep-2021 04:50
From: Richard Vincins
Subject: Anonymous postings

Good day,

Well as someone that does not post anonymously it does not bother me if others do post anonymously.  Personally, I do not find there are so many controversial postings on RAPS forum as its not a place for strong debating platform or addressing current political topics.  While there may be differences of opinions on certain topics, e.g. risk analysis, responsibilities of regulatory person, nonconformity findings, EU regulatory *cough cough* haha, they do not seem to get "out of control".  I have seen in other forums where "forum wars" ensue (like Elsmar) as people do have strong opinions concerning different topics.  Here, I think people are mostly looking for help or advice, so posting anonymously is ok because just like many training classes which I teach, Q&A session: anyone have any questions?  Silence.  Then during the breaks, I get 20 questions from 20 different people :) usually too shy or don't want to feel like - hmm as a regulatory professional I should know this answer, but I really don't.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Sep-2021 15:02
From: Ed Panek
Subject: Anonymous postings

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

I did not want to call out Elsmar specifically Ed, just an example as have seen some questionable "discussions" there :).  There are others for sure, but some of the larger community forums tend to swirl down into chaos fairly quickly depending on the subject.  I see this in other forums related to things like gaming, politics, even music and think "anonymous" just gives people large abilities to be rude to other human beings.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 08-Sep-2021 08:28
From: Ed Panek
Subject: Anonymous postings

Hi Richard,

I am a moderator on Elsmar and we are struggling with anonymous postings and people using the anonymous tag to "jump into" a thread to act as a third opinion. A debate is going on there.
Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 08-Sep-2021 04:50
From: Richard Vincins
Subject: Anonymous postings

Good day,

Well as someone that does not post anonymously it does not bother me if others do post anonymously.  Personally, I do not find there are so many controversial postings on RAPS forum as its not a place for strong debating platform or addressing current political topics.  While there may be differences of opinions on certain topics, e.g. risk analysis, responsibilities of regulatory person, nonconformity findings, EU regulatory *cough cough* haha, they do not seem to get "out of control".  I have seen in other forums where "forum wars" ensue (like Elsmar) as people do have strong opinions concerning different topics.  Here, I think people are mostly looking for help or advice, so posting anonymously is ok because just like many training classes which I teach, Q&A session: anyone have any questions?  Silence.  Then during the breaks, I get 20 questions from 20 different people :) usually too shy or don't want to feel like - hmm as a regulatory professional I should know this answer, but I really don't.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Sep-2021 15:02
From: Ed Panek
Subject: Anonymous postings

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Agree with all of the above, interesting discussion
Original Message:
Sent: 08-Sep-2021 04:50
From: Richard Vincins
Subject: Anonymous postings

Good day,

Well as someone that does not post anonymously it does not bother me if others do post anonymously.  Personally, I do not find there are so many controversial postings on RAPS forum as its not a place for strong debating platform or addressing current political topics.  While there may be differences of opinions on certain topics, e.g. risk analysis, responsibilities of regulatory person, nonconformity findings, EU regulatory *cough cough* haha, they do not seem to get "out of control".  I have seen in other forums where "forum wars" ensue (like Elsmar) as people do have strong opinions concerning different topics.  Here, I think people are mostly looking for help or advice, so posting anonymously is ok because just like many training classes which I teach, Q&A session: anyone have any questions?  Silence.  Then during the breaks, I get 20 questions from 20 different people :) usually too shy or don't want to feel like - hmm as a regulatory professional I should know this answer, but I really don't.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 07-Sep-2021 15:02
From: Ed Panek
Subject: Anonymous postings

I am unaware of the technical details but complying with the Code of Conduct Code of Conduct - RAPS Regulatory Exchange seems difficult to achieve as an anonymous poster as is being excessively utilized.

Anonymous Posting Etiquette

1. Anonymous posting should only be used in the instance where proprietary, sensitive, or otherwise delicate information is being shared that requires a members' name not to be attached to the message.

Own your postings.

Ed

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Interesting discussion!
Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Anonymous responses should stay, please don't argue against it! Some of the responses to questions are so out of date/old school thoughts which don't apply in the current regulatory environment that sometimes require a strong response anonymously! However, asking questions anonymously is what I am puzzled!

------------------------------
GRSAOnline
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Wow, really this is a reason to post anonymously? If truly there are posts that are "out of date" I don't see how a polite response that says "my recent experience has been different" or "the FDA recently changed that requirement" needs to be done anonymously. As a long time member of this forum (back into the days that there were not anonymous posts) I have generally seen people who want to help each other and are willing to learn - I certainly have not seem any flame wars because of inaccurate information. Speaking solely for myself - if I is-state something, or if there is a better way to do something, I LIKE to hear about it, because one of the things I like about this forum is that it is one of the places I can still learn something new about my profession, even being semi-retired.

Ginger



Original Message:
Sent: 08-Sep-2021 14:41
From: Narayan Rao
Subject: Anonymous postings

Anonymous responses should stay, please don't argue against it! Some of the responses to questions are so out of date/old school thoughts which don't apply in the current regulatory environment that sometimes require a strong response anonymously! However, asking questions anonymously is what I am puzzled!

------------------------------
GRSAOnline
------------------------------

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 08-Sep-2021 14:41
From: Narayan Rao
Subject: Anonymous postings

Anonymous responses should stay, please don't argue against it! Some of the responses to questions are so out of date/old school thoughts which don't apply in the current regulatory environment that sometimes require a strong response anonymously! However, asking questions anonymously is what I am puzzled!

------------------------------
GRSAOnline

I have been primarily a lurker of this forum for about three years and I rarely post, but I do want to speak on this because I do think anonymous postings allow this forum to be something that is beneficial to me and others at my career stage. 

I do not think anonymous postings are being misused by members.  I am an early/mid-stage Reg professional, and I think like many at my stage, we like the option to be able to ask our "I should probably know this!" questions anonymously.   There are many regulatory professionals on these forums, and honestly, at least from the Med Dev Reg side, I feel like it's a small world.  Posting anonymously gives the ability to ask silly questions or participate without feeling like we're "looking dumb."  If an anonymous poster is giving just bad advice, I trust people will counter it.  If an anonymous poster is trolling, intentionally disrupting a conversation, or being rude, I assume we could collectively bring that to the forum moderators attention to investigate and perhaps take action.  I don't see that here.  I feel like this is a safe place to participate in discussions and that is partially because of the ability to post anonymously.

------------------------------
Katherine Doll Kanne
Senior Regulatory Affairs Specialist
Saint Paul MN
United States
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

I haven't noticed any particular increases in anonymous postings. And I see a great need to be able to post anonymously. I have used the feature several times, and there are several reasons.

Proprietary company information
Posing a question that could get FDA's attention
Posting a hypothetical question that could put one's company in a less than stellar light

These are just a few off the top of my head. One of the great values to be gained here is experience with difficult regulatory issues. And many of these may not want to be raised if they could be linked with a company.

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Wheatland CA
United States
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Thank you all for your comments. It may have gotten lost in my original post, but I completely agree that there can be good justifications for posting questions and requests for advice anonymously.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

A neat feature would be a "Vote to block Anonymous" button. Once a certain number of votes has been received (not counting anonymous votes) the thread would automatically be closed for anonymous postings.

This could discourage and ultimately limit offending posts, while still offering anonymous posting for all the other fair reasons that others already mentioned. Great discussion, thanks for bringing it up, Glen! 

 

------------------------------
Martina Heim SCD, RAC
Director
Johns Creek GA
United States
------------------------------

Original Message:
Sent: 09-Sep-2021 09:54
From: Glen Park
Subject: Anonymous postings

Thank you all for your comments. It may have gotten lost in my original post, but I completely agree that there can be good justifications for posting questions and requests for advice anonymously.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Additional reasons for posting anonymously are that revealing one's identity could actually create liabilities (legal, career, organizational, interpersonal, corporate, etc.) for the poster depending on the nature of the post.

I also believe there is a reasonable concern about dissemination of one's information that could then be exploited/leveraged for solicitation purposes.  After all, there are a lot of consultants / marketers in this forum.

On the other hand, there are certainly valid arguments that can be made against anonymous posts where the poster should instead be able to "own [one's] postings" as Ed said.  I also have wondered at times if anonymous posters are seeding or initiating discussions so that they can subsequently with identity revealed showcase their amazingness via a precooked response.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 9/9/2021 6:12:00 PM
From: Kevin Randall
Subject: RE: Anonymous postings

Additional reasons for posting anonymously are that revealing one's identity could actually create liabilities (legal, career, organizational, interpersonal, corporate, etc.) for the poster depending on the nature of the post.

I also believe there is a reasonable concern about dissemination of one's information that could then be exploited/leveraged for solicitation purposes.  After all, there are a lot of consultants / marketers in this forum.

On the other hand, there are certainly valid arguments that can be made against anonymous posts where the poster should instead be able to "own [one's] postings" as Ed said.  I also have wondered at times if anonymous posters are seeding or initiating discussions so that they can subsequently showcase their amazingness in responding with identity revealed.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Hi Ram,

I'm not making any particular characterization about whether spamming / solicitation is bad or good.  I'm simply stating that I believe there are folks that are averse to being spammed/solicited.  And I continue to believe that there are folks who would rather not be spammed after revealing their personal information; and that there are folks who have been spammed after revealing their personal information; and that there are folks who consequently avoid revealing their personal information so as to avoid being solicited.  I would be surprised if subsequent posts herein don't eventually corroborate that position.

Time will tell I guess.  Best regards.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 09-Sep-2021 18:20
From: Ram Balani
Subject: Anonymous postings

Kevin,

 

You seem to be implying solicitations from vendors are a bad thing-not so mate, i.e  you cite one reason why folks post Anonymous is to avoid solicitations.

 

In the end – if there's a problem or issue posted --  Anonymous or not--  when posted-the forum provides a hub where there is a meeting of the minds and all stakeholders can participate with without ramming up their services or product. In the end-the Poster seeks a solution and for whatever reason-wishes to remain unnamed for a variety of reasons that has NOTHING to do with fielding solications.

 

That's what this forum is all about after all -is it not?

 

 

========================

eSTARHelper- Microsoft TEAMs

  Turbo-charge your US FDA 510(k)

  Cphi North America eSTAR Article:

   https://tinyurl.com/2wkxp69y

  

  Ram Balani

  CEO – FDASmart Inc.

 

  Phone: 201-913-0558 (Mobile)

 

  Email: rbalani@fdamart.com

 

  7 Barlow Court

  Amawalk, NY 10501

 

  www.fdasmart.com

 

                

 

 

 

Original Message:
Sent: 9/9/2021 6:12:00 PM
From: Kevin Randall
Subject: RE: Anonymous postings

Additional reasons for posting anonymously are that revealing one's identity could actually create liabilities (legal, career, organizational, interpersonal, corporate, etc.) for the poster depending on the nature of the post.

I also believe there is a reasonable concern about dissemination of one's information that could then be exploited/leveraged for solicitation purposes.  After all, there are a lot of consultants / marketers in this forum.

On the other hand, there are certainly valid arguments that can be made against anonymous posts where the poster should instead be able to "own [one's] postings" as Ed said.  I also have wondered at times if anonymous posters are seeding or initiating discussions so that they can subsequently showcase their amazingness in responding with identity revealed.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Ultimately, we want to encourage "value-added" posts regardless of origin. 

Reddit uses a vote up or vote down or no vote system to rank and promote value-added posts so those are more prominent. It makes reading posting easier as the less valuable or trolling type posts are moved down from view. This saves time getting to the core comments that are more useful.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 09-Sep-2021 18:32
From: Kevin Randall
Subject: Anonymous postings

Hi Ram,

I'm not making any particular characterization about whether spamming / solicitation is bad or good.  I'm simply stating that I believe there are folks that are averse to being spammed/solicited.  And I continue to believe that there are folks who would rather not be spammed after revealing their personal information; and that there are folks who have been spammed after revealing their personal information; and that there are folks who consequently avoid revealing their personal information so as to avoid being solicited.  I would be surprised if subsequent posts herein don't eventually corroborate that position.

Time will tell I guess.  Best regards.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 09-Sep-2021 18:20
From: Ram Balani
Subject: Anonymous postings

Kevin,

 

You seem to be implying solicitations from vendors are a bad thing-not so mate, i.e  you cite one reason why folks post Anonymous is to avoid solicitations.

 

In the end – if there's a problem or issue posted --  Anonymous or not--  when posted-the forum provides a hub where there is a meeting of the minds and all stakeholders can participate with without ramming up their services or product. In the end-the Poster seeks a solution and for whatever reason-wishes to remain unnamed for a variety of reasons that has NOTHING to do with fielding solications.

 

That's what this forum is all about after all -is it not?

 

 

========================

eSTARHelper- Microsoft TEAMs

  Turbo-charge your US FDA 510(k)

  Cphi North America eSTAR Article:

   https://tinyurl.com/2wkxp69y

  

  Ram Balani

  CEO – FDASmart Inc.

 

  Phone: 201-913-0558 (Mobile)

 

  Email: rbalani@fdamart.com

 

  7 Barlow Court

  Amawalk, NY 10501

 

  www.fdasmart.com

 

                

 

 

 

Original Message:
Sent: 9/9/2021 6:12:00 PM
From: Kevin Randall
Subject: RE: Anonymous postings

Additional reasons for posting anonymously are that revealing one's identity could actually create liabilities (legal, career, organizational, interpersonal, corporate, etc.) for the poster depending on the nature of the post.

I also believe there is a reasonable concern about dissemination of one's information that could then be exploited/leveraged for solicitation purposes.  After all, there are a lot of consultants / marketers in this forum.

On the other hand, there are certainly valid arguments that can be made against anonymous posts where the poster should instead be able to "own [one's] postings" as Ed said.  I also have wondered at times if anonymous posters are seeding or initiating discussions so that they can subsequently showcase their amazingness in responding with identity revealed.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

This is a professional RA forum helping drug/device development and post-approval maintenance industry and not a social media like Reddit, Facebook etc.......Please don't convert this forum into a social media where a person gets maximum votes or likes thinks and or make everyone think that his/her response is the correct one! This would be disaster for lot of professionals looking for right and appropriate responses to professional questions!! Majority of professional don't see any problem with anonymous posts so please leave it as is!!!
Original Message:
Sent: 10-Sep-2021 08:52
From: Ed Panek
Subject: Anonymous postings

Ultimately, we want to encourage "value-added" posts regardless of origin.

Reddit uses a vote up or vote down or no vote system to rank and promote value-added posts so those are more prominent. It makes reading posting easier as the less valuable or trolling type posts are moved down from view. This saves time getting to the core comments that are more useful.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 09-Sep-2021 18:32
From: Kevin Randall
Subject: Anonymous postings

Hi Ram,

I'm not making any particular characterization about whether spamming / solicitation is bad or good.  I'm simply stating that I believe there are folks that are averse to being spammed/solicited.  And I continue to believe that there are folks who would rather not be spammed after revealing their personal information; and that there are folks who have been spammed after revealing their personal information; and that there are folks who consequently avoid revealing their personal information so as to avoid being solicited.  I would be surprised if subsequent posts herein don't eventually corroborate that position.

Time will tell I guess.  Best regards.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 09-Sep-2021 18:20
From: Ram Balani
Subject: Anonymous postings

Kevin,

 

You seem to be implying solicitations from vendors are a bad thing-not so mate, i.e  you cite one reason why folks post Anonymous is to avoid solicitations.

 

In the end – if there's a problem or issue posted --  Anonymous or not--  when posted-the forum provides a hub where there is a meeting of the minds and all stakeholders can participate with without ramming up their services or product. In the end-the Poster seeks a solution and for whatever reason-wishes to remain unnamed for a variety of reasons that has NOTHING to do with fielding solications.

 

That's what this forum is all about after all -is it not?

 

 

========================

eSTARHelper- Microsoft TEAMs

  Turbo-charge your US FDA 510(k)

  Cphi North America eSTAR Article:

   https://tinyurl.com/2wkxp69y

  

  Ram Balani

  CEO – FDASmart Inc.

 

  Phone: 201-913-0558 (Mobile)

 

  Email: rbalani@fdamart.com

 

  7 Barlow Court

  Amawalk, NY 10501

 

  www.fdasmart.com

 

                

 

 

 

Original Message:
Sent: 9/9/2021 6:12:00 PM
From: Kevin Randall
Subject: RE: Anonymous postings

Additional reasons for posting anonymously are that revealing one's identity could actually create liabilities (legal, career, organizational, interpersonal, corporate, etc.) for the poster depending on the nature of the post.

I also believe there is a reasonable concern about dissemination of one's information that could then be exploited/leveraged for solicitation purposes.  After all, there are a lot of consultants / marketers in this forum.

On the other hand, there are certainly valid arguments that can be made against anonymous posts where the poster should instead be able to "own [one's] postings" as Ed said.  I also have wondered at times if anonymous posters are seeding or initiating discussions so that they can subsequently showcase their amazingness in responding with identity revealed.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Personally, I agree with having an option for an anonymous post.  I have from time to time used the feature previously for any of the reasons that have already been outlined (fear of connection to my company, fear of FDA visibility, fear of job or personal repercussions, etc.).  However, I generally do not post answers to questions or issues on the forum anonymously.  There is another tool that can be used if one wishes to post anonymously to the forum - inbox the original poster.  This ensures that only 1 person sees the response with your identity and eliminates some of what might be considered spamming or solicitation for people who have fears of such issues.

Look, anonymous posts can be a bit difficult to interpret (even more difficult than "normal" posts on the system) because you end up with even less context from which to understand the response or information or question.  I believe that people who are asking questions may have very valid reasons for asking anonymously and eliminating that feature could chill discussions.  I also believe that in some instances people responding to posts may have very valid reasons for posting anonymously to protect themselves, their company or in some cases, their clients.  But I do sometimes wonder if the "Post Anonymously" button is just clicked to click a button.  Generally I haven't seen a significant number of posts that I have difficulty understanding the reasons for posting anonymously, but when I do it is pretty obvious that it was either because the posting party worried about the post being inflammatory or because the post was so far over-the-top in my opinion that the post might provide amazing information but in such a manner that it was unlikely to be read completely because of the way the post was written.

Overall I agree, anonymous posts should remain as an option.  I think it provides a great vehicle to get and provide answers with at least some limitation to liability.  However, I think it is truly on all of us as posters to remember that (to use Ed's words) owning our opinions and owning our words and owning our posts provides the greatest value.  So when possible, the anonymous post option should not be the first option considered.  If it is that major a problem, a respectfully worded, I disagree or my experience was different is the best route.  Then consider the idea of providing the original poster with whom you disagree with a more precise explanation of what you disagree with (to Narayan's point earlier).  But it is interesting how we have 2 posts in this thread that were posted anonymously and simply agree with other comments and find the thread interesting.  Is that really a reason to post anonymously?  I think this is the point of what Glen was getting at....

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

If the post itself, be it a question or response, is valid and sincere I don't see any reason to include personal information.  I am not here to take part in an online community for any other reason than to find answers to my Regulatory questions and repay that with my own knowledge when I can.  Call me a curmudgeon.  If people are using anonymity to protect their bad behavior we should request RAPS include some sort of reporting feature so, anonymous or not, a user is held responsible for their actions.
Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

I work at a major multinational corporation.  In the culture of the company I work at (which is headquartered outside the US) it's frowned upon for employees to post anything publicly on the Internet.  So other than "liking" and resharing things on social media, you don't see anyone saying much.

I have many years of unique experience in a variety of roles in or adjacent to regulatory.  I am happy to share my experiences and advice on this forum, and have done so many times.  I am not really eager to post things under my name--and that is generally true across all Internet forums.  Most forums allow pseudonymity, which to me is a good balance between total anonymity and full identification.  Unfortunately this particular platform does not.

I can't foresee the ramifications of everything I post.  A very talented PhD once approached me about a job.  Many years before, in college, she had made an anonymous troll post on a closed university forum.  Her post went viral, she got outed, and the situation got media attention.  Because that media attention still dominated her Google hits years later, I couldn't give an enthusiastic recommendation to hire her--I didn't feel comfortable that a customer might search for one of our employees and find that.  At my previous employer, I also saw somebody fired a week in because of previous online activity that she probably assumed was private.

I note that almost all posters on this thread are male, and also that most of you seem significantly older than me.  As a woman from a generation who grew up with the Internet, I've had my share of bad experiences and I am probably much more protective of my privacy than your average man.  Without the option to post anonymously, I wouldn't post at all.   I have a female friend who received months of death threats due to an army of trolls on social media, had to resign from her public service position before she was ready to retire, and had to move states.  You might argue that we are all professionals in the same small field.  It doesn't matter:  I have a female academic physician friend on Twitter who was harassed by her academic physician colleagues for posting an unpopular opinion about the future of her specialty.

So that's my $0.02.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

I have made mistakes on this forum, I know I'm not perfect (none of us are) and have luckily been professionally corrected publically. I like to learn and this is a good forum for that. In the previous anonymous post you are correct that there is a possibility of being harassed or worse which would be horrible.  RAPS in general is a good professional organization but I can't speak for all in the organization obviously. I hope to never see that.  I am a proponent of anonymous posts to protect the identity of those that are shy of asking their questions, need to protect their identity for whatever reason.  I haven't seen any major abuse of this privilege.  Has anyone else seen a major abuse of this privilege?

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 10-Sep-2021 15:20
From: Anonymous Member
Subject: Anonymous postings

This message was posted by a user wishing to remain anonymous

I work at a major multinational corporation.  In the culture of the company I work at (which is headquartered outside the US) it's frowned upon for employees to post anything publicly on the Internet.  So other than "liking" and resharing things on social media, you don't see anyone saying much.

I have many years of unique experience in a variety of roles in or adjacent to regulatory.  I am happy to share my experiences and advice on this forum, and have done so many times.  I am not really eager to post things under my name--and that is generally true across all Internet forums.  Most forums allow pseudonymity, which to me is a good balance between total anonymity and full identification.  Unfortunately this particular platform does not.

I can't foresee the ramifications of everything I post.  A very talented PhD once approached me about a job.  Many years before, in college, she had made an anonymous troll post on a closed university forum.  Her post went viral, she got outed, and the situation got media attention.  Because that media attention still dominated her Google hits years later, I couldn't give an enthusiastic recommendation to hire her--I didn't feel comfortable that a customer might search for one of our employees and find that.  At my previous employer, I also saw somebody fired a week in because of previous online activity that she probably assumed was private.

I note that almost all posters on this thread are male, and also that most of you seem significantly older than me.  As a woman from a generation who grew up with the Internet, I've had my share of bad experiences and I am probably much more protective of my privacy than your average man.  Without the option to post anonymously, I wouldn't post at all.   I have a female friend who received months of death threats due to an army of trolls on social media, had to resign from her public service position before she was ready to retire, and had to move states.  You might argue that we are all professionals in the same small field.  It doesn't matter:  I have a female academic physician friend on Twitter who was harassed by her academic physician colleagues for posting an unpopular opinion about the future of her specialty.

So that's my $0.02.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

I agree with Anon. Some of us are not comfortable posting questions under our name as it is not well received in the company where we work. We value the feedback and input from this discussion forum and want to request it - hence there is a definite need to have the option to post a question Anonymously. Please do not take that option away.
I too would not be able to post questions at all without the anonymous option.

For those that can post questions/responses without fear of repercussion - lucky for you! Please be considerate of those that don't have that luxury/privelege.
Thanks
Original Message:
Sent: 10-Sep-2021 15:20
From: Anonymous Member
Subject: Anonymous postings

This message was posted by a user wishing to remain anonymous

I work at a major multinational corporation.  In the culture of the company I work at (which is headquartered outside the US) it's frowned upon for employees to post anything publicly on the Internet.  So other than "liking" and resharing things on social media, you don't see anyone saying much.

I have many years of unique experience in a variety of roles in or adjacent to regulatory.  I am happy to share my experiences and advice on this forum, and have done so many times.  I am not really eager to post things under my name--and that is generally true across all Internet forums.  Most forums allow pseudonymity, which to me is a good balance between total anonymity and full identification.  Unfortunately this particular platform does not.

I can't foresee the ramifications of everything I post.  A very talented PhD once approached me about a job.  Many years before, in college, she had made an anonymous troll post on a closed university forum.  Her post went viral, she got outed, and the situation got media attention.  Because that media attention still dominated her Google hits years later, I couldn't give an enthusiastic recommendation to hire her--I didn't feel comfortable that a customer might search for one of our employees and find that.  At my previous employer, I also saw somebody fired a week in because of previous online activity that she probably assumed was private.

I note that almost all posters on this thread are male, and also that most of you seem significantly older than me.  As a woman from a generation who grew up with the Internet, I've had my share of bad experiences and I am probably much more protective of my privacy than your average man.  Without the option to post anonymously, I wouldn't post at all.   I have a female friend who received months of death threats due to an army of trolls on social media, had to resign from her public service position before she was ready to retire, and had to move states.  You might argue that we are all professionals in the same small field.  It doesn't matter:  I have a female academic physician friend on Twitter who was harassed by her academic physician colleagues for posting an unpopular opinion about the future of her specialty.

So that's my $0.02.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

<sub>Since I work for myself, I can say when I worked at a large multinational (3M) use of social media was discouraged and there was written policy on the hoops to jump through for anything, and caveats to be included "not the company's official position".  I also presented on a panel at RAPS Convergence in 2014 and getting that through multiple management and legal reviews was a long pain for something so simple, and again, had to include the caveats.

Same issues have arisen when contracting on combination product projects for large multinationals. They all have strict written policies.</sub>

That said, when I have a question or want advice related to smaller client projects, I typically post anonymously for competitive reasons.  Small companies typically don't have restrictions on postings, but probably should because a good lawyer can use postings as fodder in a liability case "even your regulatory consultant said xxxxxxxxxxx".

Write smart.  There is a valid reason for anonymous postings.  


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 13-Sep-2021 21:27
From: Anonymous Member
Subject: Anonymous postings

This message was posted by a user wishing to remain anonymous

I agree with Anon. Some of us are not comfortable posting questions under our name as it is not well received in the company where we work. We value the feedback and input from this discussion forum and want to request it - hence there is a definite need to have the option to post a question Anonymously. Please do not take that option away.
I too would not be able to post questions at all without the anonymous option.

For those that can post questions/responses without fear of repercussion - lucky for you! Please be considerate of those that don't have that luxury/privelege.
Thanks
Original Message:
Sent: 10-Sep-2021 15:20
From: Anonymous Member
Subject: Anonymous postings

This message was posted by a user wishing to remain anonymous

I work at a major multinational corporation.  In the culture of the company I work at (which is headquartered outside the US) it's frowned upon for employees to post anything publicly on the Internet.  So other than "liking" and resharing things on social media, you don't see anyone saying much.

I have many years of unique experience in a variety of roles in or adjacent to regulatory.  I am happy to share my experiences and advice on this forum, and have done so many times.  I am not really eager to post things under my name--and that is generally true across all Internet forums.  Most forums allow pseudonymity, which to me is a good balance between total anonymity and full identification.  Unfortunately this particular platform does not.

I can't foresee the ramifications of everything I post.  A very talented PhD once approached me about a job.  Many years before, in college, she had made an anonymous troll post on a closed university forum.  Her post went viral, she got outed, and the situation got media attention.  Because that media attention still dominated her Google hits years later, I couldn't give an enthusiastic recommendation to hire her--I didn't feel comfortable that a customer might search for one of our employees and find that.  At my previous employer, I also saw somebody fired a week in because of previous online activity that she probably assumed was private.

I note that almost all posters on this thread are male, and also that most of you seem significantly older than me.  As a woman from a generation who grew up with the Internet, I've had my share of bad experiences and I am probably much more protective of my privacy than your average man.  Without the option to post anonymously, I wouldn't post at all.   I have a female friend who received months of death threats due to an army of trolls on social media, had to resign from her public service position before she was ready to retire, and had to move states.  You might argue that we are all professionals in the same small field.  It doesn't matter:  I have a female academic physician friend on Twitter who was harassed by her academic physician colleagues for posting an unpopular opinion about the future of her specialty.

So that's my $0.02.

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Let's say you are working in industry.  Current advice you can offer probably comes from something your company is doing, or has done.  If I anonymously say "I sped up the submission of X by submitting an abbreviated 510k," that is general advice that may be really helpful to some RA person making a random product who has never heard of an abbreviated 510k.  If on the other hand, that advice is traceable back to me, it catches the attention of competitors making my specific product:  "Hmm...company X is using abbreviated 510k's. We should try that too."
 
If I am working at a regulatory body, I also don't want to be giving advice associated with my name or regulatory body lest it be construed as "official."

I suppose I could put disclaimers on all my posts saying "this is my opinion, not my employer's"--but blah.  And in practice, is anyone really going to be able to separate those anyway?  Let's say I am an FDA reviewer or manager in a particular area.  Whatever I post will be interpreted--maybe correctly--as FDA thinking.  I may have a ton of advice to offer, but without anonymous posting I won't be able to post at all.

So at least for me it has nothing to do with having confidence in what I say, or personal ownership of it.  I post anonymously because I want to help, but I don't want blowback onto the organization I work for, nor do I want to be perceived as representing their opinions, nor do I want to share information with my competitors.  I can offer more advice and be of more value to people on this forum in an anonymous capacity.

So Glen--that's another perspective.  I definitely don't base my regard for people in this community on whether or not they post advice anonymously.  If anything it seems to me that the people who post frequently and publicly receive accolades and credits and attention from the community, as well as consulting business and networking benefits--whereas the people who post anonymously do so to give back to the community, without any recognition at all.
Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

This message was posted by a user wishing to remain anonymous

I don't see anything wrong with the anonymous posts here ¯\_(ツ)_/¯
Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

I'll admit, I have had the same thoughts as Glen in his original post. I completely understand why people would post a question anonymously, but, as someone else mentioned, I have seen anonymous responses that made me wonder why they felt the need to post anonymously. Some of the responses here have given me new perspectives, and I appreciate that. It did occur to me that someone's organization might have a particularly strict policy about posting on the internet. And I understand that there are people who are just not comfortable putting any personally identifiable information on the internet.

However, I will say that I tend to discount opinions posted anonymously, particularly if they are presented in a somewhat aggressive manner (which here generally means using exclamation points).

I will also admit that I completely suck at posting anonymously. If I post a question anonymously, I'll often feel the need to respond to the responses - to ask a follow-up question or justify a position or whatever - and I'll forget to tick the anonymous box and accidentally out myself. So I just don't bother, lol.

------------------------------
Rachel Thornton
Associate Director
Smyrna GA
United States
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Several years ago I wrote to this forum opposing the use of anonymous in the signature. I have reversed myself because of an understanding that relates to proprietary and planning interests of a company, fear of management and general concern about negative responses especially when an opinion is given. Having been in the consulting business for almost 40 years and 10+ years in industry as a vice president at Warner-Lambert and department head at Hoffman LaRoche I can appreciate the concerns expressed by anonymous writers to the forum. 

As a member of RAPS for 35 years as well as belonging to other organizations  it has without a doubt one of the best member and public forum I have had the honor of participating in.

Bottom line leave the anonymous signature..

------------------------------
Robert Schiff PhD, RAC, CQA, FRAPS
CEO
Schiff & Company, Inc.
583 Mountain Avenue
North Caldwell, NJ 07006
rschiff13@aol.com
973-568-3361
------------------------------

Original Message:
Sent: 07-Sep-2021 12:17
From: Glen Park
Subject: Anonymous postings

This will probably be controversial, but something I have been thinking of for a while.

Members of our community very often post strong opinions in response to questions or comments and do so anonymously. I completely understand why some questions and requests for advice need to be posted anonymously as they can be related to sensitive company policies/activities. However, I think stating opinions and advice under anonymous cover is a problem for our community. If we have opinions or advice for others, we should take ownership of those opinions. If we are not confident in what we say, it is still fine to own it with caveats and qualifications. If you can't own an opinion or position to your colleagues, how can you defend yourself in your company? I have a high regard for those in our community that post opinions and advice under their own names. Anonymous - not so much.

I have posted opinions - at least once - anonymously but only because the topic was directly related to something my company was doing at the time.

Other thoughts?

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------