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
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.
Program Agenda
| 8:30 AM – 09:00 AM | Spot Registration + Breakfast + Introduction |
| 09:00 AM - 10:30 AM | Discussion on :
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| 10:30 AM - 10:45 AM | Tea/Coffee Break |
| 10:45 AM - 12:15 PM | How to prepare for an FDA Inspection :
|
| 12:15 PM - 01:15 PM | Lunch |
| 01:15 PM - 02:45 PM | How to handle the FDA when on site:
|
| 02:45 PM - 03:00 PM | PM Break |
| 03:00 PM - 04:45 PM | What the FDA does after the inspection:
The Sign or Sue letter:
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| 04:45 PM - 05:00 PM | Q&A – Conclusion |
Registration Information
- Registration Fee : USD $299
- For assistance on registration, please send an email to
marketing@biopractice.com or
Please call: Ph - 1-646-216-8860