14th Annual FDA Inspections Summit

precon
12:00 p.m. – 1:00 p.m. Registration
1:00 p.m. – 5:00 p.m. Flawless FDA Inspection Handling and Response
1:00 p.m. – 5:00 p.m. Process Validation for Medical Devices: Preparing for a QSR Inspection
1:00 p.m. – 5:00 p.m. ICH E6(R2): How to be Inspection Ready with Your Sponsor Risk Management Program

12:00 p.m. – 1:00 p.m.

Registration


Drugs & Biologics Preconference Workshop

1:00 p.m. – 5:00 p.m.

Flawless FDA Inspection Handling and Response

John Avellanet of Cerulean Associates — one of the industry’s top inspectional readiness experts — is back to teach proven techniques to manage FDA investigators on-site, how to defend yourself where it’s appropriate and craft 483 responses that fend off warning letters.

Compliance pros know that getting an FDA investigator in and out as quickly as possible is the best strategy. The longer an FDA investigator is on site, the more likely you’ll be handed a multi-page 483.

And if you think racking up those observations is bad, even worse is crafting a response, plowing it through your internal departments and getting it back to the FDA in just 15 days.

You’ll learn how to prepare for an inspection, how to encourage the investigator to see you in a state-of-control, and how — if the worst happens — to manage a 483 observation and not get a warning letter.

Attendees will discover:

  • The results of a case study of how a firm that passed 9 previous inspections suddenly failed under the FDA's new inspection technique
  • Critical inspection preparation techniques every member of your team must commit to memory — especially useful for those surprise FDA visits
  • Hidden tactics FDA investigators use to test your controls and are taught to probe your answers for weakness
  • How to speed the inspection to minimize the risk of 483 observations, while always remaining respectful
  • What really needs to be in your regulatory inspection handling SOPs — tips for cutting corporate-speak and unnecessary verbiage that doesn’t help
  • How to write an inspection response designed to reduce the likelihood of a warning letter — and tips and tricks to get sign-offs quickly from even the toughest groups (like legal)
  • What FDA staff look for in your replies and the top red flags they notice

Attendees will receive:

  • A sample regulatory inspection handling SOP — ready for your immediate implementation
  • Three inspection handling and response checklists — ready for you to use right away
  • An observation-closure matrix — ready to speed you out of FDA trouble

John Avellanet, Managing Director and Principal, Cerulean Associates LLC


Medical Devices Preconference Workshop

1:00 p.m. – 5:00 p.m.

Process Validation for Medical Devices: Preparing for a QSR Inspection

Nearly half of every warning letter issued to medical device companies in 2018 cited process validation as a problem. That’s a big problem.

Process validation can be a daunting prospect. What should you do? When should you do it? What records should you keep?

With no clear guidance from the FDA, finding the answers can be difficult.

Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, as he discusses the fundamental requirements of medical device process validation. Dan will walk you through his analysis of warning letters and help you apply lessons learned.

Dan O’Leary, President, Ombu Enterprises, LLC


Clinical Trials Preconference Workshop

1:00 p.m. – 5:00 p.m.

ICH E6(R2): How to be Inspection Ready with Your Sponsor Risk Management Program

The clinical trials world is going back to school. Recent ICH E6(R2) guidelines require trial sponsors to institute risk assessment at both the system and clinical trial levels; and require drug and biologics makers to qualify vendors.

You can get all the training you need to meet these challenges with four hours of hands-on professional development aimed at helping you understand and comply with new ICH E6(R2) requirements. Teaming up with Technical Resources International Inc., we’ve created a workshop that meets the needs of everyone along the clinical trials spectrum, from trial sponsors to trial operators and overseers.

Risk assessment helps drug and biologics makers master the intricacies of the new guidelines with interactive training. You’ll discuss:

  • What the new guidelines require
  • How to establish your program step-by-step
  • Critical elements of starting your program: A walk-through
  • How to conduct risk assessment at both system and clinical trial levels
  • Evaluating the risks: Your options
  • Risk mitigation and reporting strategies
  • Common pitfalls and how to sidestep them

Susan Leister, Vice-President, Quality & Compliance, Technical Resources International

 


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