Regulatory Open Forum

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message------

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

​Hi.

I actually have experience with both the Johns Hopkins program and the Northeastern program.  A colleague and I went through our MS degrees at the same time through different programs, he went through Northeastern and I went through JHU.  I thought both programs well rounded but I really thought that the JHU program had an interesting twist to the degree.  The last class of the program can be a "seminar" class where it is really almost a role-play where you would be assigned 2 or 3 projects during the semester.  For each project there would be a "team" but you worked individually as a different stakeholder in the approval process for a real product that was marketed to attempt to represent the position of the stakeholder at FDA advisory meetings.  So, someone would be an FDA reviewer, another person represented the company, a third person represented the patient community, someone else might represent any of the non-governmental organizations that could either be in favor of or completely against the approval of the product.  While many of us work in the regulated industry and are using the MS to further our careers quite often, the fact that I had to think like the president of an NGO for one of my projects forced me out of my comfort zone and made me try to think like a person on the other side of the discussion and then forced me to understand the arguments that were likely to be made.  I think this has served me very well in my own work because I now try to think of what disagreeing arguments I might make before I deal with an issue so I can work through the process of how to best respond to the disagreement.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

I teach at JHU and GWU and agree that the last practical class is important. I was on the committee at JHU that recommended it, in fact. I have let 3 students work the practical class with me at FDA.
I believe that the program at JHU is not as good as it was 5 or 10 years ago, though.
GWU School of Medicine and Health Science has an excellent program.
Take a look at the differences between each program and chose the one you will succeed at. GW, for example, has 8-week semesters that students like because they can take a semester off when work gets crazy and be back on track in 8 weeks.
As to Northeastern, I have talked to hiring managers that will not hire or even interview from that program because they think very little of it.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Online MS and Certificate Programs

Temple		remove preview
Online MS and Certificate Programs Drug Development Certificate, Basic Pharmaceutical Development, Medical Devices, Biopharmaceuticals and Generic Drugs, Clinical Trial Managment, Global Pharmacovigilance: Benefit/Risk Assessment, Labeling, Advertising and Promotions, and Post Master's Certificates in Advanced QA and RA. View this on Temple >

------------------------------
Gaurang Bhavsar, MS, RAC
Scientist-II, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Thank you everyone for the valuable suggestions. I really appreciate your time.

Bhupinder Singh

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

​I would echo Mark Duval's recommendation of the MS program in RA at St. Cloud State University if you are in the medical devices field.  I graduated from the program in 2015; I think I was the first remote student to go through the program, but more have gone through since.  You attend classes live via Adobe Connect (and a headset) in the evenings and/or Saturday mornings.  It is not an online pre-recorded at-your-own-pace type of program; most of the class is present there in Minneapolis.

Before I started the St. Cloud program, I researched every online program there was at the time.  I created a pros/cons spreadsheet.  Several programs looked good, but St. Cloud's was the only one dedicated specifically and solely to medical devices.  Other programs touched on medical devices but didn't focus solely on them. 

Embarking on a program like this while working full-time and having a family is hard enough, so I wanted to make sure the program content was focused on what I wanted to learn.  I had no interest in the pharmaceutical industry, so I went with the only program focused solely on medical devices.  For me, the program curriculum was perfect, the instructors were names I already knew from many of their speaking roles at RAPS meetings, and the curriculum was very challenging.  I can't say enough positive things about the program there if your field of interest is medical devices.

Now, I encourage all of our QA and RA people to go through the program.  Two recently received promotions in part due to the experience they gained in going through the QA program.  Message me if you have any questions.

Good luck!


------------------------------
Shane Shuttlesworth
Osteogenics Biomedical
Lubbock TX
United States
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message------

​I would echo Mark Duval's recommendation of the MS program in RA at St. Cloud State University if you are in the medical devices field.  I graduated from the program in 2015; I think I was the first remote student to go through the program, but more have gone through since.  You attend classes live via Adobe Connect (and a headset) in the evenings and/or Saturday mornings.  It is not an online pre-recorded at-your-own-pace type of program; most of the class is present there in Minneapolis.

Before I started the St. Cloud program, I researched every online program there was at the time.  I created a pros/cons spreadsheet.  Several programs looked good, but St. Cloud's was the only one dedicated specifically and solely to medical devices.  Other programs touched on medical devices but didn't focus solely on them. 

Embarking on a program like this while working full-time and having a family is hard enough, so I wanted to make sure the program content was focused on what I wanted to learn.  I had no interest in the pharmaceutical industry, so I went with the only program focused solely on medical devices.  For me, the program curriculum was perfect, the instructors were names I already knew from many of their speaking roles at RAPS meetings, and the curriculum was very challenging.  I can't say enough positive things about the program there if your field of interest is medical devices.

Now, I encourage all of our QA and RA people to go through the program.  Two recently received promotions in part due to the experience they gained in going through the QA program.  Message me if you have any questions.

Good luck!


------------------------------
Shane Shuttlesworth
Osteogenics Biomedical
Lubbock TX
United States
------------------------------

Good to hear from you Shane. I know the positive impact the RAS, MTQ and ACR programs at St. Cloud State have on the individuals as well as the positive impact on the companies that have people who have completed the program. Hope all continues on a strong path at Osteogenics!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Regulatory and Quality Solutions
Becker MN
United States
------------------------------

Original Message:
Sent: 10-Nov-2017 11:35
From: Shane Shuttlesworth
Subject: MS ( Regulatory Affairs)

​I would echo Mark Duval's recommendation of the MS program in RA at St. Cloud State University if you are in the medical devices field.  I graduated from the program in 2015; I think I was the first remote student to go through the program, but more have gone through since.  You attend classes live via Adobe Connect (and a headset) in the evenings and/or Saturday mornings.  It is not an online pre-recorded at-your-own-pace type of program; most of the class is present there in Minneapolis.

Before I started the St. Cloud program, I researched every online program there was at the time.  I created a pros/cons spreadsheet.  Several programs looked good, but St. Cloud's was the only one dedicated specifically and solely to medical devices.  Other programs touched on medical devices but didn't focus solely on them.

Embarking on a program like this while working full-time and having a family is hard enough, so I wanted to make sure the program content was focused on what I wanted to learn.  I had no interest in the pharmaceutical industry, so I went with the only program focused solely on medical devices.  For me, the program curriculum was perfect, the instructors were names I already knew from many of their speaking roles at RAPS meetings, and the curriculum was very challenging.  I can't say enough positive things about the program there if your field of interest is medical devices.

Now, I encourage all of our QA and RA people to go through the program.  Two recently received promotions in part due to the experience they gained in going through the QA program.  Message me if you have any questions.

Good luck!


------------------------------
Shane Shuttlesworth
Osteogenics Biomedical
Lubbock TX
United States

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

I believe Temple U has the best RAQA M.S.: different fields coverage, and experts from industry, Pfizer, Sanofi etc. etc.
It is pricy but I did my own research and the classes offered there are very practical so I went there and got the degree.

------------------------------
Artur Shchukin
New York NY
United States
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

I sincerely echo again the notes from Mark and Shane. As the former Director of the MTQ program, I had several people tell me about both promotions and getting the next position (while going through the program). In addition, the impact all 3 programs there have on companies has been amazing as well.

A couple more items...they have an annual career fair at the campus in the Minneapolis area for current students and alumni and since there are the 3 programs (Regulatory, Quality and Clinical) you have an opportunity to take those classes as electives to better understand those areas as well.

If there are any other questions about the programs at SCSU, please message me and I will connect you with the current program directors.Good luck in your choice and your career!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Regulatory and Quality Solutions
Becker MN
United States
------------------------------

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Just my two cents - 

As a current 1st year student in the St. Cloud State University Regulatory Affairs and Services (RAS) program, I have been a bit underwhelmed from my coursework so far.   

Although the courses are taught by working professionals in the medical device area, which does provide a great perspective, it is almost a disservice to the students.  Several of the courses are taught by multiple instructors and these instructors seem to communicate very little with each other in ways of coordinating course material.  There's a lot of repetition within a single class and not a very clear direction of where the class is heading - and then there's also not a lot of coordination between class to class that repetition occurs across classes.  I understand that some repetition is necessary as some students take different paths through the program, but I almost feel like the 33-36 credits to finish the M.S. degree could probably be accomplished in closer to 16 credit hours.

Is it a good program?  Sure.  I just believe there is a lot of room for improvement, too.  From what I hear, there's been a good amount of turnover in the course instructors in recent years and perhaps it'll just take some time for the newer instructors to really get into the swing of things and provide more concise, coordinated and timely classes (it's infuriating to be in a four hour night class that runs 30 minutes over time because the two instructors didn't communicate their lecture schedule well).   Also --- the courses need to change with the times, too.  Will the RAS/MTQ programs see a MDSAP or ISO 13485 course at some point?

I just wanted to provide my perspective here to perhaps balance what I see as a lot of cheerleading for the SCSU program on this forum; some constructive criticism to the right ears (or eyes) just might help make this program better.  My experience and opinion is my own, and I'm not trying to speak for the other students in my classes (many of whom are currently seeking employment in the medical device field).

I have no experience to provide a comparison to the other programs that are available out there, but I do know I'll be looking into other MN-Twin Cities alternatives like Hamline's law-focused medical device classes and St. Thomas' medical device courses per my employer's suggestion.  Needless to say, I am definitely questioning if $780 a credit hour is worth the investment at this point in time.  From my current perspective and experience, I do not intend on finishing the program. 

Oh, and Mark DuVal - I look forward to your first and final class presentation for my Legal Basis for Medical Product Registration class tomorrow evening. As you might suspect, I have some high expectations.  ;)
Original Message:
Sent: 11-Nov-2017 09:35
From: Mark Swanson
Subject: MS ( Regulatory Affairs)

I sincerely echo again the notes from Mark and Shane. As the former Director of the MTQ program, I had several people tell me about both promotions and getting the next position (while going through the program). In addition, the impact all 3 programs there have on companies has been amazing as well.

A couple more items...they have an annual career fair at the campus in the Minneapolis area for current students and alumni and since there are the 3 programs (Regulatory, Quality and Clinical) you have an opportunity to take those classes as electives to better understand those areas as well.

If there are any other questions about the programs at SCSU, please message me and I will connect you with the current program directors.Good luck in your choice and your career!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Regulatory and Quality Solutions
Becker MN
United States

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Hello,

There are many well respected RAQA certificate and masters program available. Most are predominantly taught by facility in the industry and are classroom or web based. Only familiar with three programs, and attended the one.

Full disclosure, graduated from the Temple U program. My background was in clinical, medical devices and IVDs. Selected Temple because I wanted to know more about Pharma. The curriculum was much broader than just "drugs".The offerings were challenging and would apply to all aspects of the FDA regulated industries.

It's a top notch program and provided the necessary tools and contacts to round out my professional aspirations. 

Carol

------------------------------
Carol Cooper, MS, RAC
CM Cooper & Associates
Libertyville IL
United States
------------------------------

Original Message:
Sent: 12-Nov-2017 10:13
From: Anonymous Member
Subject: MS ( Regulatory Affairs)

This message was posted by a user wishing to remain anonymous

Just my two cents -

As a current 1st year student in the St. Cloud State University Regulatory Affairs and Services (RAS) program, I have been a bit underwhelmed from my coursework so far.

Although the courses are taught by working professionals in the medical device area, which does provide a great perspective, it is almost a disservice to the students.  Several of the courses are taught by multiple instructors and these instructors seem to communicate very little with each other in ways of coordinating course material.  There's a lot of repetition within a single class and not a very clear direction of where the class is heading - and then there's also not a lot of coordination between class to class that repetition occurs across classes.  I understand that some repetition is necessary as some students take different paths through the program, but I almost feel like the 33-36 credits to finish the M.S. degree could probably be accomplished in closer to 16 credit hours.

Is it a good program?  Sure.  I just believe there is a lot of room for improvement, too.  From what I hear, there's been a good amount of turnover in the course instructors in recent years and perhaps it'll just take some time for the newer instructors to really get into the swing of things and provide more concise, coordinated and timely classes (it's infuriating to be in a four hour night class that runs 30 minutes over time because the two instructors didn't communicate their lecture schedule well).   Also --- the courses need to change with the times, too.  Will the RAS/MTQ programs see a MDSAP or ISO 13485 course at some point?

I just wanted to provide my perspective here to perhaps balance what I see as a lot of cheerleading for the SCSU program on this forum; some constructive criticism to the right ears (or eyes) just might help make this program better.  My experience and opinion is my own, and I'm not trying to speak for the other students in my classes (many of whom are currently seeking employment in the medical device field).

I have no experience to provide a comparison to the other programs that are available out there, but I do know I'll be looking into other MN-Twin Cities alternatives like Hamline's law-focused medical device classes and St. Thomas' medical device courses per my employer's suggestion.  Needless to say, I am definitely questioning if $780 a credit hour is worth the investment at this point in time.  From my current perspective and experience, I do not intend on finishing the program.

Oh, and Mark DuVal - I look forward to your first and final class presentation for my Legal Basis for Medical Product Registration class tomorrow evening. As you might suspect, I have some high expectations.  ;)
Original Message:
Sent: 11-Nov-2017 09:35
From: Mark Swanson
Subject: MS ( Regulatory Affairs)

I sincerely echo again the notes from Mark and Shane. As the former Director of the MTQ program, I had several people tell me about both promotions and getting the next position (while going through the program). In addition, the impact all 3 programs there have on companies has been amazing as well.

A couple more items...they have an annual career fair at the campus in the Minneapolis area for current students and alumni and since there are the 3 programs (Regulatory, Quality and Clinical) you have an opportunity to take those classes as electives to better understand those areas as well.

If there are any other questions about the programs at SCSU, please message me and I will connect you with the current program directors.Good luck in your choice and your career!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Regulatory and Quality Solutions
Becker MN
United States

Original Message:
Sent: 08-Nov-2017 13:11
From: Bhupinder Singh
Subject: MS ( Regulatory Affairs)

Hello,

Any recommendation for good online accredited university for MS (Regulatory Affairs)

Thanks,

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message------

Hello,

There are many well respected RAQA certificate and masters program available. Most are predominantly taught by facility in the industry and are classroom or web based. Only familiar with three programs, and attended the one.

Full disclosure, graduated from the Temple U program. My background was in clinical, medical devices and IVDs. Selected Temple because I wanted to know more about Pharma. The curriculum was much broader than just "drugs".The offerings were challenging and would apply to all aspects of the FDA regulated industries.

It's a top notch program and provided the necessary tools and contacts to round out my professional aspirations. 

Carol

------------------------------
Carol Cooper, MS, RAC
CM Cooper & Associates
Libertyville IL
United States
------------------------------

Original Message------

I'm currently in the Northeastern University MS program and, though it's only my first semester, I can't recommend it enough. I feel the courses are well established and organized, the instructors very knowledgeable, and the material covered is current and appropriate. The student support, even for online students, is wonderful and so helpful.

It is a 45 quarter credit hour course, so it does take some time, but I really think it's worth it.

 

Good luck in your academic search,

Kim

 

[CONFIDENTIALITY AND PRIVACY NOTICE] Information transmitted by this email is proprietary to Medtronic and is intended for use only by the individual or entity to which it is addressed, and may contain information that is private, privileged, confidential or exempt from disclosure under applicable law. If you are not the intended recipient or it appears that this mail has been forwarded to you without proper authority, you are notified that any use or dissemination of this information in any manner is strictly prohibited. In such cases, please delete this mail from your records. To view this notice in other languages you can either select the following link or manually copy and paste the link into the address bar of a web browser: http://emaildisclaimer.medtronic.com

Original Message------

Question Kim, do academic professors with little or no industry experience teach the courses or adjunct professors who are working in industry?  It makes a difference for practical learning, application and eventual placement.  

Mark DuVal, JD, FRAPS

President & CEO

DuVal & Associates, P.A.

Sent from my Verizon, Samsung Galaxy smartphone

Each of our instructors has an average of 10-15 years of professional experience in the field of global regulatory affairs.  We firmly embed experiential learning concepts into our curriculum.  Additionally, within the Northeastern Graduate Regulatory Affairs Program(s) you can concentrate in one of 6 different specialties within the field.  Moreover, every single student that graduates from our MS-RA Program will do so with professional experience on their resume/CV.  You can also complete the degree online or at any one of our 5 campus locations:  Boston, Charlotte, Toronto, Seattle, Silicon Valley.  Take a look:

Online Medical Regulatory Affairs Masters Degree | Medical Regulatory Affairs Degree-Northeastern College of Professional Studies

Neu		remove preview
Online Medical Regulatory Affairs Masters Degree | Medical Regulatory Affairs Degree-Northeastern College of Professional Studies Northeastern designed this unique program to deepen your understanding of regulations in the development and marketing of drugs, biologics, and medical device products. View this on Neu >

Steve Amato
Faculty Director, Graduate Regulatory Affairs and Life Sciences
Northeastern University
s.amato@northeastern.edu

------------------------------
Stephen Amato, PhD, MBA, RAC
Northeastern University
Boston MA
United States
------------------------------

Original Message:
Sent: 16-Nov-2017 08:56
From: Kimberly Parker Howard
Subject: MS ( Regulatory Affairs)

All the professors in my program actually currently work in the field.

 

[CONFIDENTIALITY AND PRIVACY NOTICE] Information transmitted by this email is proprietary to Medtronic and is intended for use only by the individual or entity to which it is addressed, and may contain information that is private, privileged, confidential or exempt from disclosure under applicable law. If you are not the intended recipient or it appears that this mail has been forwarded to you without proper authority, you are notified that any use or dissemination of this information in any manner is strictly prohibited. In such cases, please delete this mail from your records. To view this notice in other languages you can either select the following link or manually copy and paste the link into the address bar of a web browser: http://emaildisclaimer.medtronic.com

Original Message------

Question Kim, do academic professors with little or no industry experience teach the courses or adjunct professors who are working in industry?  It makes a difference for practical learning, application and eventual placement.  

Mark DuVal, JD, FRAPS

President & CEO

DuVal & Associates, P.A.

Sent from my Verizon, Samsung Galaxy smartphone

​Temple University's RA QA program just celebrated it's 50th anniversary! It was the first university to offer graduate education in regulatory affairs and quality assurance and continues to be the gold standard in this discipline. The program offers 80+ courses in Regulatory Affairs, Quality Assurance, Medical Devices, Biotechnology, Biosimilars, Generic Drugs, Clinical Trials, Regulatory Intelligence, Pharmacovigilance and more. Courses available both online, on campus, or a mixture of the two. And they are all live, allowing for active engagement between instructor and student. Many of the courses are available on weekends.

Temple's instructors are leaders in industry and FDA.

To learn more about the program http://www.temple.edu/pharmacy_qara/    

I have been teaching on campus courses at Temple since 1998. If you have any questions about the program feel free to reach out to me or to the Assistant Dean of the Program, Wendy Lebing, at QARA@temple.edu.