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Understanding FDA Guidelines and Preparing for Audits

May 17-18, 2018
  • Alexandria, VA

CBI’s Compounding Pharmacy Compliance 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.

WHAT ARE THE TOP BENEFITS FOR DELEGATES?

  • Learn about the latest FDA guidelines
  • Discuss jurisdiction complexities between FDA and
    Pharmacy State Boards
  • Gain a greater understanding of how respond to 483 letters
  • Participate in a 1.5 hour workshop on preparing for an audit
  • Network with peers who are preparing their facilities and
    dealing with the same issues

IN-DEPTH SESSIONS:

  • Understanding and conforming to USP 800 guidelines
    and how it relates to changes with USP 797
  • Navigating compliance with both the FDA and the
    pharmacy state board
  • Common 483 violations and how to avoid them
  • Quality assurance of your supply chain
  • Proper audit planning
  • Enhanced enforcement activity in the compounding world
  • Effective response strategies to 483 warning letters and
    observations