FDA’s New Inspection Approach - Webinar CD/Transcript

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FDA’s New Inspection Approach: What Your Inspector Knows in Four Hours

FDA investigators generally know within four hours of an inspection whether you’re in trouble or not. If you are on their “good” list, they’ll merely ask you to reassure them you know what you’re doing. If you’re on the “bad” list, get ready to convince them you know what you are doing because they don’t like what they’re seeing.

Reassuring is relatively easy. Convincing is hard.

Like death and taxes, FDA inspections – and their skeptical investigators – will never go away. CDER Director Janet Woodcock has made it clear one of her top priorities in 2015 is the launch of a new “super office” called the Office of Pharmaceutical Quality and implementing the new Inspectional Corps Re-organization.

While these sound innocuous enough these changes have pumped some new enthusiasm into investigators with a promise of earlier, centralized and more stringent risk assessments and inspections among other developments drug makers need to know.

Now more than ever you need a thorough review of your compliance program and battle plan for when that investigator is waiting in the lobby.

That’s the stick. Now here’s the carrot: FDA is also considering a new inspection scoring system that would, for the first time, recognize drugmakers that go beyond normal compliance with enhanced good manufacturing practices. The system is part of a brand spanking new inspections protocol project aimed at revamping the inspection process so that CDER inspectors have a better idea of a facility’s state of quality.

Now more than ever, drug makers need to understand the “new normal” of FDA inspections.

This session will feature tips and tricks such as:

  • How to handle FDA document requests. (Hint: Find a “copy” and “confidential” stamp first).
  • Tips for writing Roadmap Documents for investigators that cover major systems and processes — these documents have been proven to impress investigators
  • How to know when a FDA inspector is “testing” you with a particular on-site request. (Hint: Sometimes they want you to be stubborn).
  • How to ask questions during the inspection that give you a good sense of how it’s going without angering or putting the inspector on guard. (Hint: Ask how you can help).
  • How to answer trick FDA “open” questions. (Hint: They want you to keep talking. You shouldn’t)
  • 5 important points that should be covered in your inspection SOP
  • From the trenches war stories about actual inspections — could makeup, no access signage, or fishing expeditions end up as 483 violations?
  • What’s the current best practice on allowing investigators to take possession of electronic files?  Do you have a policy in writing that covers this?
  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Quality inspection and test managers
  • Process development staff
  • Training managers
  • Regulatory affairs and compliance professionals
  • Potential SMEs for inspection

Rich Yeaton, President, Atlantic Technical and Validation Services
Rich Yeaton is president of Atlantic Technical and Validation Services (formerly East Coast Validation Services) and has over 25 years of experience working in FDA-regulated industries. He was initially introduced to GMP operations for medical devices as a development engineer in DuPont’s medical products division. Subsequently, Mr. Yeaton moved on to help start Phoenix Imperative, an engineering and validation consulting company serving the biopharm industry. At Phoenix he led validation teams to assist MedImmune to obtain its first two commercial licenses. He has since worked with small startup companies and larger operating companies such as Shire, Merck, Genzyme, Wyeth and Lonza. Mr. Yeaton has in-depth experience with facility shutdowns and startups. He recently assisted Avecia Biologics, a microbial fermentation contract manufacturer, to successfully prepare for its first pre-approval inspection. He is currently working with a GMP operating company to manage process, cleaning and equipment validation efforts for a new combination product under development. Mr. Yeaton is a member of ISPE, PDA and AAMI and has degrees in electrical engineering and mechanical engineering from Lehigh University.