This conference is critical for pharmacy owners, QA/QC managers, and Pharmacists in Charge to gain a greater understanding of regulatory expectations and how to prepare and address an audit as well as effectively communicate with your inspector. An expert speaking faculty will dissect various complexities regarding compliance with the FDA and pharmacy state boards, CGMP guidelines and standard operating procedures.

Speakers: Rachael G. Pontikes

Event Type: Seminar

Location Name:
Westin San Diego, 400 West Broadway, San Diego CA 92101
Start Date/Time:
27 September 2018
End Date/Time:
28 September 2018

Partner Rachael Pontikes will be presenting Anatomy of An FDA Audit — A Tour of the Audit and An Explanation of What, When and Why.

This session will cover:

  • Why the FDA is in your facility
  • Requests of documentation and beginning of interviews
  • What to expect from the exit inspection meeting
  • Findings, review and description with provision of violations and deficiencies
  • Presentation of Notice of Observations (Form 483)
  • The Establishment Inspection Report (EIR)
  • The dispensation of warning letters