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EAGLE'S 2020
VIRTUAL
SEMINAR
Pharmacy Compounding Compliance
November 3, 2020
Protecting Your Business Through Compliance
Tuesday, November 3, 2020
"The Inspection" - Movie
Premiering During Eagle's 2020
Virtual
Seminar. Tuesday, November 3, 2020
Register
Today
interactive, Educational & entertaining
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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

Learn More

Dr. Ross Caputo

Expert Microbiologist and sought-after consultant with over 30 years in the FDA regulated pharmaceutical industry.

Learn More

7

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

An icon graphic of a man looking at a laptop

The Knock at the Door

It can happen any time. Learn how to stay inspection-ready

icon of two people keeping a distance.

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.

Eagle Analytical