Regulatory Open Forum

Dear members.

Recently I completed the Regulatory Affairs Certificate Course in Pharmaceuticals and am looking for some guidance on what courses I should pursue to complete my dual certification (Medical Devices) from RAPS.

For Pharmaceuticals, apart from the mandatory courses, I have completed the following courses -

• Chemistry, Manufacturing and Controls (CMC)
• FDA Law and Regulation
• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)

For the dual certificate upgrade, I can take 3 more courses apart from 2 mandatory courses.
Can anyone suggest what would be best for someone who has no experience in medical device area.
Here are my options -

• Medical Devices: Postmarket Surveillance
• Medical Devices: Risk Management
• Medical Devices: US Regulations
• Medical Devices: Compliance and Audits
• Medical Devices: Corrections, Removals and Directed Recalls
• Introductory Medical Writing
• Medical Devices: Advertising and Promotion in the US

Although there are more courses, I personally believe I will have to focus on the basics first and then work my way up.
Please guide me.

Kind regards.

Reji

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Reji Nair
Scientist, HPLC
Trace-Ability, Inc
Culver City, CA
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Hi,

The Introductory Medical Writing course and the Intermediate Medical Writing: Medical Devices would be useful.  Although I am new to regulatory affairs, it seems to me most job postings for a Regulatory Affairs Specialist state applicants should have some knowledge of regulatory writing.

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(Leigh) Beth Latham, PhD, CCRC
Clinical Research Coordinator II
The University of Texas Health Science Center at Houston
Houston,TX
United States
------------------------------

Original Message:
Sent: 16-Sep-2017 14:26
From: Reji Nair
Subject: Online Certification course

Dear members.

Recently I completed the Regulatory Affairs Certificate Course in Pharmaceuticals and am looking for some guidance on what courses I should pursue to complete my dual certification (Medical Devices) from RAPS.

For Pharmaceuticals, apart from the mandatory courses, I have completed the following courses -

• Chemistry, Manufacturing and Controls (CMC)
• FDA Law and Regulation
• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)

For the dual certificate upgrade, I can take 3 more courses apart from 2 mandatory courses.
Can anyone suggest what would be best for someone who has no experience in medical device area.
Here are my options -

• Medical Devices: Postmarket Surveillance
• Medical Devices: Risk Management
• Medical Devices: US Regulations
• Medical Devices: Compliance and Audits
• Medical Devices: Corrections, Removals and Directed Recalls
• Introductory Medical Writing
• Medical Devices: Advertising and Promotion in the US

Although there are more courses, I personally believe I will have to focus on the basics first and then work my way up.
Please guide me.

Kind regards.

Reji

------------------------------
Reji Nair
Scientist, HPLC
Trace-Ability, Inc
Culver City, CA
------------------------------