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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.

Sessions and discussion include:

  • Learn about the latest FDA guidelines
  • Discuss jurisdiction complexities between FDA and
    Pharmacy State Boards
  • Study how to respond to 483 letters, and what to do next
  • Participate an in-depth workshop on preparing for an audit
  • Network with peers who are preparing their facilities and
    dealing with the same issues
  • Understanding and conforming to USP 800 guidelines and how it relates to changes with USP 797 and 795
  • Navigating compliance with both the FDA and the
    pharmacy state board
  • Common 483 violations and how to avoid them
  • Proper audit planning
  • Enhanced enforcement activity in the compounding world
  • Effective response strategies to 483 warning letters and observations
  • Stability Testing
  • Registration process with the FDA
  • Specialty sterile compounding of hormone replacement
  • Compounding Hormone Replacement Therapies from bulk ingredients
  • Updates re the NIOSH hazardous drug list

Compounding Pharmacy Compliance West

Understanding FDA Guidelines and Preparing for Audits

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.

Sessions and discussion include:

  • Learn about the latest FDA guidelines
  • Discuss jurisdiction complexities between FDA and
    Pharmacy State Boards
  • Study how to respond to 483 letters, and what to do next
  • Participate an in-depth workshop on preparing for an audit
  • Network with peers who are preparing their facilities and
    dealing with the same issues
  • Understanding and conforming to USP 800 guidelines and how it relates to changes with USP 797 and 795
  • Navigating compliance with both the FDA and the
    pharmacy state board
  • Common 483 violations and how to avoid them
  • Proper audit planning
  • Enhanced enforcement activity in the compounding world
  • Effective response strategies to 483 warning letters and observations
  • Stability Testing
  • Registration process with the FDA
  • Specialty sterile compounding of hormone replacement
  • Compounding Hormone Replacement Therapies from bulk ingredients
  • Updates re the NIOSH hazardous drug list