Pharmacy Compounding Compliance
Improving Your Business and Operations through Compliance
A Pre-Seminar Conference Sponsored by Eagle
Tuesday, November 3, 2020

“Inspection” The Movie — Premiering 2 days before International Seminar 2020!

Don’t miss the limited release of this live-action thriller, featuring members of the Eagle team! The presenters will show various FDA inspection scenes, then provide feedback to the audience on the “whys” and “what ifs,” including the reasoning behind each. This will be an interactive experience. Attendees are encouraged to engage with the presenters by asking questions and discussing topics in-depth.

Registration is open to all PCCA members and Eagle clients. However, registration for this event is not included in the International Seminar registration fee.

Ross Caputo
PhD, Eagle President

Ross A. Caputo, PhD, President of Eagle, earned his PhD in Microbiological Physiology and Immunology from Miami University in 1976, and has over 30 years of experience in the FDA-regulated pharmaceutical industry on sterilization research and aseptic processing focusing on process optimization and control. He has authored more than 50 publications and owns 15 patents, all related to infection control, sterilization processes and the production of sterile product.

David Hussong
PhD, Eagle Chief Technical Officer

David Hussong, PhD, joined the Eagle team in January 2018, and has over 40 years of experience, including 30 years with the FDA as a regulatory scientist. Most recently, he was a consultant to the pharmaceutical industry. His research has been focused on studies of microbial recovery and detection methods. He is currently the chair of the USP Microbiology Expert Committee. In Dave’s position as Chief Technical Officer, he assists in scientific and regulatory matters for analytical testing of products and pharmacy support services.

Karla Palmer

Karla Palmer has over 25 years of experience as a litigator. Her focus at Hyman, Phelps & McNamara, P.C., is on DEA and FDA enforcement and litigation matters. Karla also advises clients throughout the supply chain on a range of issues, including DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings. In addition, she has written about and addressed industry audiences on all aspects of the passage and implementation of the 2013 Drug Quality and Security Act, including both compounding and supply chain issues, its guidance documents and implementing regulations. She is well-versed on the DSCSA and on compounding laws, regulations and guidance, and regularly counsels clients throughout the nation on these matters.

CE credit will not be offered for this program.

9:00 am

Scene 1: The Knock at the Door

  • Interactive Discussion: Preparing for Regulatory Inspections
  • Presentation: Understand the Requirement to Maintain 503A Status
  • Q&A

10:00 am

Break

10:10 am

Scene 2: Through the Pharmacy with the Investigator

  • Interactive Discussion: Appropriate Behavior During Inspections; Inside the Mind of the FDA
  • Presentation: What are insanitary conditions? How do I spot them? How do I correct them?
  • Q&A
11:10 am

Break

11:20 am

Scene 3: Processes, Procedures, Documentation

  • Interactive Discussion: Process
  • Presentation: What documents do I need in order to prove a safe product? What is my quality system?
  • Q&A
12:20 pm

Break

12:30 pm

Scene 4: Conclusion

  • Interactive Discussion: Getting Product Out the Door/Distribution
  • Presentation: What do I need to focus on for future activities? What systems are stretched? What is my weak link? How do I handle 483 responses? Recalling of purchased components?
  • Conclusion: Establishing a Continual Learning Environment
  • Q&A

Pricing

PCCA Members & Eagle Clients – $195.00 Per Pharmacy

Registration fee includes access to educational programming for the entire pharmacy team, plus:

  • Education app with all presentations in electronic format
  • Downloadable audio recording of the event
  • Video recording available for viewing for 6 months post-event

Registration is open to all PCCA members and Eagle clients.

Billing and Cancellation Policy

Credit cards will be billed immediately. For those members who select the Bill Account option, billing for PCCA International Seminar registrations will occur immediately following the event. Full refunds available through Wednesday, October 28, 2020. The registration fee will not be refunded for any cancellations received after Wednesday, October 28, 2020, including no-shows. If you are unable to attend, you will still receive an audio recording of the event plus video recording access for 6 months post-event. If you do not receive your confirmation letter within one week, please call to confirm receipt of your registration.

If you do not receive your confirmation letter within one week, please call to confirm receipt of your registration.

Viewing Logistics

An email that includes the virtual conference login and app details will be sent to all registrants by 4 pm CT one day before the event begins. Full instructions will be included in the email.