FDA Form 483 and Warning Letter - Understanding FDA Procedure

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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 4-Advisory 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/t-AOhq5l2It2 (This link will valid only for April 16,2023)