FDAnews Announces: CAPA: Noun or Verb? — How Good is Your Containment Program? Webinar, April 28, 2015

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For decades, CAPA has been the number one item cited by the FDA in 483s. In this webinar, noted CAPA expert James (Rusty) Lusk will teach attendees how to stress-test their CAPA programs and subsequently identify and address any weaknesses.

CAPA: Noun or Verb?
How Good is Your Containment Program?
**FDAnews Webinar**
April 28, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/capanounorverb

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 the 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 webinar, noted CAPA expert James (Rusty) Lusk will teach attendees how to stress-test their CAPA programs and subsequently identify and address any weaknesses.

They 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.

Attendees 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

Attendees 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.

Who Will Benefit:
This course will be of benefit for:

  • 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

Conference Details:
CAPA: Noun or Verb?
How Good is Your Containment Program?
**FDAnews Webinar**
April 28, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/capanounorverb
Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/capanounorverb
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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