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This training will help viewers to understand many topics related to FDA Form 483 and Warning Letter Understanding FDA Procedure.
Below points are discussed during this session
Possible Regulatory or Enforcement Pathways
What is a Form FDA 483?
What should I do during the closing discussion and Form FDA 483 review?
Post FDA 483 – How to Respond?
What Should Your Response Include?
Understanding of warning letter.
Issuing Warning Letters Factors to Consider by FDA
Purpose of issuing a warning letter
Ongoing or Promised Corrective Actions
Response Letter
Verification of Corrective Actions
Multiple Centre Review
Warning Letters Response – Time Frame
Link to download Regulatory Procedures Manual September 2018 Chapter 4Advisory Actions https://www.fda.gov/media/71878/download
Link to download FDA Compounding QualityCenter of Excellence What to ExpectAfter an Inspection https://www.fda.gov/media/156347/down...
Link to download the training material https://we.tl/tAOhq5l2It2 (This link will valid only for April 16,2023)