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FDA Form 483 and Warning Letter - Understanding FDA Procedure

Join this channel to get access to perks:    / @hitendrakumarshah3718   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)