Understanding FDA Guidelines and Preparing for Audits
- 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
Compounding Pharmacy Compliance
Understanding FDA Guidelines and Preparing for Audits
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