FDA REMS Inspection Guide: Audit Preparedness Best Practices


Following the April 2018 implementation of the FDA compliance program document describing their Risk Evaluation and Mitigation Strategy (REMS) Inspection program, they have been ramping up focus on REMS inspections.  If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard.




Following the April 2018 publication of their Risk Evaluation and Mitigation Strategy (REMS) inspection program guide, FDA has ramped up focus on REMS inspections. REMS itself was established on September 27, 2007, as a new section of the Food and Drug Administration Amendments Act (FDAAA).  It authorizes FDA to require persons submitting or holding certain applications to present a proposed risk mitigation strategy if FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks.

Submission of REMS is a specific FDA requirement that impacts both US and non-US companies planning US submissions. An understanding of REMS requirements is important to avoid gaps in FDA submissions and during REMS inspections.  Furthermore, an increased focus on REMS inspections by the FDA calls for increased attention to risk mitigation activity execution and documentation.

If your company has a planned FDA submission or an existing REMS program in the US, don’t be caught off guard!  Attending this webinar will provide you with…

  • A “crash course” on the REMS program
  • REMS requirements as outlined by FDA
  • How to execute a quality-assured REMS program
  • What FDA inspectors specifically look for when evaluating compliance to an approved REMS, plus data showing inspections trends

Additionally, this course will teach you to perform an internal gap analysis or audit to proactively identify, document and mitigate any existing gaps before the FDA shows up with the new compliance guide in their pocket.


At the completion of this session, you will be able to:

  • Understand and discuss key points of the FDA REMS Program including their new inspector guideline
  • Execute a gap analysis or internal audit to identify existing gaps in your REMS
  • Determine how to best document your gap analysis (and outcomes) to demonstrate due diligence considering the uptick in FDA REMS inspections


This course will be of benefit to employees at all levels working in a GCP regulated environment who set strategy for, manage, execute, and/or audit pharmaceutical clinical trial and post-marketing activities including but not limited to:

  • Clinical Development
  • Clinical Operations
  • Project Management
  • Regulatory Affairs
  • Medical Writing
  • Quality Systems (Quality Assurance, Training, Document Management, etc.)
  • Drug Safety/Pharmacovigilance
  • Risk Management



This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.


Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.


Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

Additional information


Recorded Only


Single Participant, 5 Participant Value Package, 10 Participant Value Package


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