Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all,

I am preparing to start my ​doctorate in Quality Systems and Improvement Management and I am looking for insight into topics which I can cover in my dissertation. I have to ensure that I discuss quality in my topic, but I want to merge my passion of Regulatory Affairs and combination products with quality. I have a general idea, but I would love any insight into more detailed topics you may be able to offer!

Regulatory approaches to Artificial Intelligence.

I think that is very relevant and AI provides unique challenges to the regulatory environment because of how it learns and provides varying output based on the same input.

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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
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Original Message:
Sent: 25-Jan-2022 00:32
From: Anonymous Member
Subject: Dissertation topics

This message was posted by a user wishing to remain anonymous

Hello all,

I am preparing to start my ​doctorate in Quality Systems and Improvement Management and I am looking for insight into topics which I can cover in my dissertation. I have to ensure that I discuss quality in my topic, but I want to merge my passion of Regulatory Affairs and combination products with quality. I have a general idea, but I would love any insight into more detailed topics you may be able to offer!

Whatever topic you choose, you will spend a lot of time working with it.  Choose something that fascinates you.

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Anne LeBlanc
United States
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Original Message:
Sent: 25-Jan-2022 11:39
From: Ed Panek
Subject: Dissertation topics

Regulatory approaches to Artificial Intelligence.

I think that is very relevant and AI provides unique challenges to the regulatory environment because of how it learns and provides varying output based on the same input.

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

Original Message:
Sent: 25-Jan-2022 00:32
From: Anonymous Member
Subject: Dissertation topics

This message was posted by a user wishing to remain anonymous

Hello all,

I am preparing to start my ​doctorate in Quality Systems and Improvement Management and I am looking for insight into topics which I can cover in my dissertation. I have to ensure that I discuss quality in my topic, but I want to merge my passion of Regulatory Affairs and combination products with quality. I have a general idea, but I would love any insight into more detailed topics you may be able to offer!

Innovative uses of data analysis in a hybrid drug/device QMS...

Ginger

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

Original Message:
Sent: 25-Jan-2022 00:32
From: Anonymous Member
Subject: Dissertation topics

This message was posted by a user wishing to remain anonymous

Hello all,

I am preparing to start my ​doctorate in Quality Systems and Improvement Management and I am looking for insight into topics which I can cover in my dissertation. I have to ensure that I discuss quality in my topic, but I want to merge my passion of Regulatory Affairs and combination products with quality. I have a general idea, but I would love any insight into more detailed topics you may be able to offer!