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Understanding FDA Guidelines and Preparing for Audits

September 27-28, 2018
  • San Diego, CA

CBI's Compounding Pharmacy Compliance West is the only event that specifically addresses compliance challenges facing both 503A and 503B compounding pharmacies.

Through a mix of general sessions and dual 503A and 503B tracks our expert faculty will lead discussions and interactive learning sessions to best help pharmacy organizations come under compliance and address FDA and State Pharmacy Board audits.


  • Enhanced enforcement activity in the compounding world
  • Understand and conform to USP 800 guidelines and how they
    relate to changes with USP 795 and 797
  • Anatomy of an FDA audit
  • Explanations of requirements for compliant stability studies
  • How to navigate compliance with both the FDA and
    the Pharmacy State Board
  • Effectively creating registration and product reporting of
    human drug compounding outsourcing facilities
  • Review of FDA guidance for use of bulk powders

The CDER continued to crack down on compounding-related issues, conducting more than 140 inspections of compounders in the U.S., issuing more than 55 warning letters to compounders and overseeing nearly 40 recalls.

FDA Regulatory and Compliance Monthly Recap — May 2018, Loeb & Loeb LLP