Events / Webinar

503A & B Compounding FDA Inspection Readiness and Compliance Training

In-Person or Virtual

We are offering this complimentary 503 GMP training with our experts to provide guidance on readiness with the requirements of the current regulations for 503A/B facilities and current industry trends. Included are sessions for key questions and answers for the current FDA requirements for GMP 6 system approach for outsourcing facilities. This is a great opportunity to partner.

Key Takeaways

Focused Guidance on 503A/B Compliance: The training offers expert insights to help facilities align with current regulations for 503A and 503B compounding pharmacies.

In-Depth Coverage of GMP 6-System Approach: Sessions will address key FDA requirements related to the GMP six-system framework for outsourcing facilities, including Q&A opportunities.

Free Opportunity for Industry Collaboration: As a complimentary training, it’s positioned as a valuable chance to gain knowledge and connect with experts and industry peers.

Ready to get started? Connect with us to schedule your complimentary training session with Tayl’r Hollis who leads RCA’s Compounding Pharmacy initiative, where she partners with 503A and 503B organizations worldwide to enhance compliance, FDA readiness, and operational performance. Learn more about Tayl’r here and reach out using the contact us form below today to begin the process of setting up your customized training session today.

 

Use the Contact Form Below to Start the Registration Process

 

This course will cover

  • How to prepare for an FDA 503b inspection
  • The basics of a compliant environmental and personnel monitoring program
  • What you need to know about Data Integrity & GDP
  • Aseptic processing and technique, the importance of the operator’s role in patient safety
  • Insanitary conditions and the importance of shop floor walkthroughs
  • Certification in the ISO 5 and ISO 7 areas
  • Common pitfalls of cleaning and disinfection in the ISO 5 and ISO 7 areas
  • Media Fills

Presenters

Anita Michael

Executive Principal Consultant, Pharma Compliance

Anita Michael has over 25 years of global pharmaceutical regulatory and quality experience. She spent 16+ years at the U.S. FDA as a Global Pharmaceutical Expert, leading nearly 300 inspections worldwide across biotech, sterile manufacturing, drug substance, and OTC product lines. Anita has held executive and director-level roles in Quality Assurance, Regulatory Affairs, and Validation. She is a recognized industry leader in GMP inspection readiness, FDA response strategy, and modern quality system design, and has been a keynote speaker at numerous global conferences. Her contributions have earned her multiple awards from both the FDA and the pharmaceutical industry.

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Contact us to learn more about our regulatory compliance experts and how they can help


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