12th Annual FDA Inspections Summit

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. To QSIT or Not To QSIT – That is not the Question!

12:00 p.m. – 1:00 p.m.


Drugs & Biologics Preconference Workshop

1:00 p.m. – 5:00 p.m.

Flawless FDA Inspection Handling and Response

Rated #1 Pre-Conference Workshop in Inspection Summit History
Updated for FDA’s New Inspection Techniques!

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.

Plus, in a special portion of this must-attend pre-conference, he’ll explain how the FDA’s New Inspection Protocol Project inspection technique could trip up companies that have always had good compliance records. He’ll profile a company that had years of clean inspections, only to be blindsided with a bad inspection based on NIPP. You can’t afford to miss this session!

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 are bad, even worse is crafting a response, plowing it through your internal departments and getting it back to the FDA in just 15 days. Oh, did we mention the response must be detailed, provide a well-documented root cause analysis and spell-out solutions to assure the problem never happens again?

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 learn:

  • The results of a case study of how a firm that passed 9 previous inspections suddenly failed under FDA's new NIPP 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.

To QSIT or Not To QSIT – That is not the Question!

Customized, Interactive and Full Of Valuable Take-Aways,
This Pre-Conference Workshop is a Must Attend

Some industry experts and ex-FDAers are saying that QSIT is outdated, incomplete and FDA investigators are not always following the Guide to Inspections of Quality Systems, QSIT during inspections. It’s true FDA inspections can vary and many times investigator’s may not follow QSIT to the letter. So, what then is a device manufacturer to do to prepare?

Device manufacturers can spend time focusing on why it’s not fair, or they can focus on being ready for anything. This interactive pre-conference workshop will do just that.

FDAnews is proud to have Medical Device Inspection expert Julie Larsen, Principal/Director, Inspection Readiness Services at BioTeknica, provide her insights for preparing for inspections, including risk based approaches and using the QSIT’s details to assure your next inspection is squeaky clean.

Julie knows Inspections, the inspection guidances, the QSIT guidance, and how to prepare device companies of all sizes and all product classes. In just four hours, you’ll learn the current issues in application of this important inspection technique and numerous take-away ideas you can put to immediate use.

This interactive workshop will dive deep into these key issues:

  • Applying risk principals to inspection preparation
  • Pros and cons of using the QSIT’s specifics to assure your internal audits have covered and confirmed compliance with FDA’s expectations
  • Examples of companies that have used the QSIT in both positive and negative ways — many of these will surprise you!
  • Tips and tricks for being uber-prepared — especially being prompt with answers to investigators’ questions and being able to produce documents in a timely manner
  • Experiential learning for SMES through simulated inspections

Unlike other preconferences you’ve attended in the past, Julie will break attendees into working groups to flush out inspectional problems attendees are having. She’ll then offer her insights on the best-in-class tools available and best practices to solve your problems.

  • BONUS: In addition to Julie’s expert tips, attendees will receive these MUST-HAVE reference documents worth the registration fee alone, including:
  • A detailed Inspection preparation checklist that attendees can immediately apply to their current inspection prep SOP
  • 10 key questions to use in assessing your company’s state of readiness for an FDA QSIT inspection

Julie Larsen, Principal/Director, Inspection Readiness Services, BioTeknica

Braulio Ortiz, Principal/Project Manager/Senior Quality Engineer, BioTeknica, Inc.



Preconference | Day 1 | Day 2

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