|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.||No More 483s - QSIT Secrets to Assure Clean Inspections|
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.
No More 483s - QSIT Secrets to Assure Clean Inspections
Customized, Interactive and Full Of Valuable Take-Aways,
This Pre-Conference Workshop is a Must Attend
Recently, a top FDA investigator — in a candid moment — said “I’m still amazed I can go to a firm and they haven’t read the QSIT guide.”
After 18 years, too many devicemakers ignore the Quality System Inspection Techniques (QSIT) Guidance to their peril.
FDAnews is proud to have QSIT expert Julie Larsen, Principal/Director, Inspection Readiness Services at BioTeknica, provide her secrets for using the QSIT’s details to assure your next inspection is squeaky clean.
Julie knows the QSIT guidance, and how to apply it, to device companies of all sizes and all product classes. In just four hours, you’ll learn the hidden traps inside this important inspection technique and several take-away ideas you can put to immediate use.
This interactive workshop will dive deep into these key issues:
- How to use 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
- Best industry tools for internal audits
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 QSIT 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