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Recorded Webinar

How To Respond To FDA 483s

timelapse 60 Min with 15 Min QnA of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

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.

Key Areas Covered During the Webinar:

  • Recovery options from an FDA 483
  • 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
  • Discussion will include methods for maintaining a continuous quality improvement program
  • Provide methods for avoiding FDA-483 observations
  • Good Practices on how to verbally respond to FDA-483 observations during the exit meeting


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