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NJHA Conference & Event Center
760 Alexander Road, PO Box 1
Princeton, New Jersey

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Live Corporate Seminar

International Seminar on How To Respond To FDA 483s

insert_invitation Friday, 18th September, 2026
access_time 09:00 AM - 03:00 PM EST |
timelapse with 30 mins of Q and A

Note:

Post session, copy of presentation slides will be shared
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Speaker/Presenter

Brian G. Nadel

President

Brian G. Nadel GMP Consulting LLC

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Short Abstract

We are pleased to announce the premier edition of ‘Response to 483s’ Webinar. As you will agree, responding to 483s is one of the major challenges being faced by Quality Heads from pharmaceutical companies. With the USFDA keeping a close check on observations in a Pharma facility, it is imperative that we provide knowledge on best practices to respond effectively and sincerely to a 483 being issued by the USFDA.

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Program Agenda

8:30 AM – 09:00 AM Spot Registration + Breakfast + Introduction
09:00 AM - 10:30 AM Recent trends and Review of 483s :
  • Enlisting the problems and assigning a solution to each of it
  • Trend analysis
  • Recovery options from an FDA 483
10:30 AM - 10:45 AM Tea/Coffee Break
10:50 AM - 12:00 PM Devising a CAPA for your 483 :
  • Root Cause Identification to understand where the problem lies and linking it to QMS
  • Impact Assessment
  • Devising a strong CAPA
  • Effective checks on CAPA
12:00 PM - 01:00 PM Lunch
01:00 PM - 02:30 PM Continuity and commitment after writing a thorough response
  • Thinking like the FDA
  • Relating observations to the apt Quality Management System
  • Getting ready for the next audit – Do’s and dont’s considering your 483 inspection
  • Best practises to devise a sincere response with a follow up plan
02:30 PM - 03:00 PM Q&A – Conclusion

Registration Information

  • Registration Fee : USD $199
  • For assistance on registration, please send an email to marketing@biopractice.com or Please call: Ph - 1-646-216-8860
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