RECORDED SEMINARS

Recorded Seminar

International Seminar on FDA Inspections in the 21st Century

timelapse Full Day followed by Breakfast & Lunch
with 30 mins of Q and A

Note:

Recorded Seminar can be played unlimited times
Along with recorded seminar, copy of presentation slides will be shared

Speaker/Presenter

J. Lawrence Stevens, RAC

FDA Regulatory Expert

Consultant, One Way Consultants, LLC

Short Abstract

The goal of this seminar is to prepare you for the “new” FDA and the way FDA now conducts inspections of regulated firms. As technology has advanced so has FDA perhaps not at the same rate, but the FDA of today is not the same one of 20 years ago. We will discuss how FDA conducts inspections, how you should handle inspections, what kind of problems can occur during an inspection, and how to assure a positive outcome of any FDA inspection.


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Program Agenda

8:30 AM – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 AM - 10:30 AM Discussion on :

  • FDA Inspectional Authority
  • Types of FDA Inspectors :

    • FDA Compliance Programs
    • Compliance Inspections
    • For Cause Inspections
10:30 AM - 10:45 AM Tea/Coffee Break
10:45 AM - 12:15 PM How to prepare for an FDA Inspection :

  • Compliant Quality Systems
  • Internal audits
  • Contract audits
12:15 PM - 01:15 PM Lunch
01:15 PM - 02:45 PM How to handle the FDA when on site:

  • Pre Notification or not
  • Who talks to FDA
  • An audit agenda?
  • How to know the inspection is going wrong
  • How to resolve issues during an inspection
  • How to respond to an FDA 483
02:45 PM - 03:00 PM PM Break
03:00 PM - 04:45 PM What the FDA does after the inspection:

  • Turbo EIR
  • The FDA Warning Letter


The Sign or Sue letter:

  • How to avoid one
  • What it means to receive one
  • Why you do not want a Voluntary Injunction
04:45 PM - 05:00 PM Q&A – Conclusion

Registration Information

  • Registration Fee : USD $599
  • For assistance on registration, please send an email to marketing@biopractice.com or
    Please call: Ph - 1-646-216-8860
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