The FDA website is really well done.
General courses are here.
To get the nuance you want, you should review the videos on CDERLearn and CDRHLearn.
The FDA CDER (Center for Drug Evaluation and Research) offers free, self paced, web based courses here. More announcements and course details can be accessed from below FDA links.
See also
CDER Small Business and Industry Assistance (SBIA) Learn which includes conference recordings.
CDRH Learn courses are on the
FDA website here and on
YouTube here.
FDA history is here.
Let me know if your company needs a course. I am available to help out.
Regards------------------------------
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 as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
------------------------------
Original Message:
Sent: 27-Jan-2023 10:43
From: Anonymous Member
Subject: Resources regarding US statutes and regulations
This message was posted by a user wishing to remain anonymous
Colleagues,
Does anyone have a recommendation for one or more resources (eg, courses, webinars) that can be used to gain a more comprehensive understanding of US statutes and regulations applicable to drug/biologic development and life cycle management?
Ideally, the resource would involve more than a mention of statutes and a "read-through" of regulations. For example, it would be helpful to have some historical perspective (such as underlying issue that resulted in a statutory requirement and its associated regulation) in addition to practical application of these in the life of a regulatory professional.
I suspect that a comprehensive resource may not be readily available and seek input regarding how best to address knowledge and experience deficits of new regulatory professionals.
Many thanks