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Thank you for reading this post, don't forget to subscribe!The Most Unique Compounding Seminar You’ll Ever Attend!
Come experience “edutainment” as we premiere “The Inspection,” a Movie portraying real-life scenarios from FDA inspections at compounding facilities. You’ll learn how to handle one of the industry’s most dreaded events…regulatory inspections.
This entertaining and interactive virtual seminar will give attendees a chance to ask questions after each scene and presentation. Our experts will provide feedback to the audience on the “whys” and “what ifs,” including the reasoning behind each.
Get equipped to implement systems that will help your facility become compliant. With the ever-evolving nature of compounding regulations, all sterile and non-sterile compounding personnel must attend this event! Space is limited.
Registration Fee: $195 / facility
We’ve made sure that this seminar is affordably-priced with one flat registration fee per company! Here’s an opportunity for all compounding facility staff to learn together to ensure everyone understands this crucial information.
Exclusive Insight from the FDA Agent’s Training Manual
You will learn how to handle an inspection based on what FDA investigators are taught to look for. Thorough the presentations, you will understand the basic requirements of quality systems, 503A exemptions, preventing insanitary conditions and how to avoid the regulatory consequences of noncompliance.
Dr. David Hussong
Former FDA Associate Director for New Drug Microbiology
Current Chairman of the USP Microbiology Expert Committee
Dr. Ross Caputo
Expert Microbiologist and sought-after consultant with over 30 years in the FDA regulated pharmaceutical industry.
KARLA PALMER, J.D – Director at Hyman, Phelps & McNamara
Karla Palmer, one of the nation’s top litigation experts on FDA 483 & Risk Mitigation issues, will be joining Dr. Ross Caputo and Dr. David Hussong as one of the presenters at this exciting virtual seminar.
As a litigator with 25 years’ experience, Karla advises clients throughout the pharmaceutical supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of legal and regulatory issues. These matters include DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings.
Insanitary Conditions
Are you making these common mistakes which have led to regulatory consequences?
Quality Systems Development
Are personnel engaging in best practices? Do your systems qualify to ensure patient safety?
Topics Will Include
Practical Lectures That Will Help Safeguard Your Business
The Knock at the Door
It can happen any time. Learn how to stay inspection-ready
Appropriate Conduct During Inspections
What to do, and what NOT to do during regulatory inspections
What is FDA looking for in my documentation, processes, and procedures
What will investigators be looking for? Strengthen your quality system
Responding to investigations
How to respond to a 483? How to handle recalls. Establishing appropriate training systems
Agenda - Tuesday, November 3, 2020
9:00 a.m.
Scene 1: The Knock at the Door
- Interactive Discussion & Presentation: Preparing for Regulatory Inspections & Understanding the Requirements to Maintain 503A Status
- Q&A
10:00 a.m.
BREAK
10:10 a.m.
Scene 2: Through the Pharmacy with the Investigator
- Interactive Discussion & Presentation: Insanitary Conditions & Inspection Do’s and Don’ts
- Appropriate Behavior During Inspections. Inside the Mind of the FDA. What are Insanitary conditions? How do I spot them? How do I correct them?
- Q&A
11:10 a.m.
BREAK
11:20 a.m.
Scene 3: Processes, Procedures, Documentation
- Interactive Discussion & Presentation: Documentation
- What documents do I need in order to prove a safe product? What is my quality system?
- Q&A
12:20 p.m.
BREAK
12:30 p.m.
Scene 4: Conclusion
- Interactive Discussion & Presentation: Responding to Investigations
- Handling 483 responses, Recalls, and other inspection outcomes.
- Conclusion
- Q&A
1:30 p.m.
DISMISS
Registration Fee: $195 / facility
We’ve made sure that this seminar is affordably-priced with one flat registration fee per company! Here’s an opportunity for all compounding facility staff to learn together to ensure everyone understands this crucial information.
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