CAPA: Noun or Verb? - Webinar CD/Transcript

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CAPA: Noun or Verb? – How Good is Your Containment Program?

For decades, CAPA has been the number one item cited by the FDA in 483s. It’s the first thing FDA inspectors look at when they tell your receptionist they’re waiting in the lobby. But many firms don’t understand some of the most important issues underlying a good CAPA program.

Think CAPA is a noun? Think again. A strong CAPA program is about containment. It’s about taking action. CAPA is a verb.

In this presentation, noted CAPA expert James (Rusty) Lusk will teach you how to stress-test their own CAPA programs and subsequently identify and address any weaknesses.

You will also learn to understand the FDA’s position — the only one that really matters — and how to build a CAPA program that coverts their current noun-centric approach to a verb-centric one.

You will learn:

  • The importance of “the zone” — the most effective part of a CAPA system where the thought process and the documentation process overlap to truly produce results
  • To identify and solve the five common CAPA problems
    • Nothing changes as a result of a CAPA
    • No evidence of effectiveness
    • Solution does not fit the problem
    • CAPAs open too long — sometimes months and months
    • Wrong stuff in the CAPA system
  • How to compare and contrast two common problem solving methods:  DMAIC (Six Sigma) and Military
  • How to use effective flow charts to determine when to trigger a CAPA
  • How to write CAPA reports — with proper supporting documentation — that FDA investigators will accept

You will receive 2 BONUSES:

15-Point CAPA Checklist:  This checklist — provided to attendees in MS-Word and customizable to their operations — will detail all the steps necessary to move CAPAs from nouns to verbs.  It will require companies to take action on CAPAs and make the necessary systems and personnel changes necessary to assure problem do not repeat themselves.  This checklist alone is worth the price of admission.

Containment Gap Analysis:  In Rusty’s research and work on the subject, one of the most commonly overlooked facets of CAPA is product containment.  This presentation will present a game plan for assuring that product identified as problematic by a CAPA is contained in plant, product on the market is investigated and potentially removed and sister facilities that might be experiencing the same problems properly notified and included in the solution.

This course will be of benefit:

  • QA/QC personnel
  • Compliance personnel
  • Manufacturing and operations executives
  • Process validation and lean Six Sigma experts
  • Regulatory affairs professionals
  • SOP development and training executives
  • Kit manufacturers and repackages

James (Rusty) Lusk, has more than 35 years of experience in regulated and non-regulated industries ranging from early-stage development to Fortune 100 companies. He has held senior management positions in disciplines such as regulatory, quality, clinical programs, and new business development. He is currently a Principal with Quality Systems International; a multidiscipline consulting company serving ISO and FDA regulated industries. He is also co-founder of LifePulse, LLC, an early-stage medical device company and co-inventor of a non-invasive device intended to delay or reverse cardiovascular disease and improve quality of life.

He is currently an active member of Orange County Regulatory Affairs (OCRA) discussion group, a nonprofit organization with the mission of educating the regulatory professional, having held various positions to include President. Mr. Lusk received his MBA from Pepperdine University and his BS in Biological Sciences from The University of California, Irvine.