FDAnews Announces: Conducting Advanced Root Cause Analysis CAPA Investigations, Oct. 23-24, 2017, Arlington, VA

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The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important. FDAnews and LearningPlus are offering an advanced version of their previous CAPA investigations class that emphasizes investigating to find the root, contributing, and proximal causes — things that are essential to know to create an effective CAPA.

Conducting Advanced Root Cause Analysis CAPA Investigations:
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by FDAnews and Learning Plus**
Oct. 23-24, 2017 – Arlington, VA
http://www.fdanews.com/capapc

The greatest threat to compliance is ... overconfidence.

Take CAPA. Manufacturers may think they have it down pat. But CAPA failures show up year after year in about half of all warning letters.

Come to Arlington, VA this October for two days of intense CAPA training sponsored by FDAnews.

Under the guidance of a nationally recognized CAPA expert, attendees will discover new paths to improved CAPA compliance, dispel mystifying myths and misunderstandings and set themselves up for better relations with the FDA and global regulators too.

  •     The FDA is continually enforcing CAPA requirements? Get up to speed on key regulatory requirements both at home and abroad.
  •     Companies may be great at getting CAPA procedures in place, yet fail when it comes to executing them? Here’s how to clear away those barriers.
  •     The too-often-neglected process of properly opening and closing CAPAs can trigger warning letters? Get the big picture and gain start-to-finish discipline.

The CAPA coach, Jim Vesper, has guided thousands of individuals through the maze called CAPA. With more than 25 years of experience in GMP and investigation training, he’s seen every problem and answered every question you may have.

Come ready to work, hard. It’s a tough schedule — two full days of intensive training.

The payoff? A wealth of practical knowledge, tips, tools and techniques to put into effect right away. Here’s just a taste of what attendees will discover:

  •     Regulators’ expectations regarding investigations, CAPAs and investigation reports
  •     How to use accident/incident models when conducting investigations
  •     Six different accident/incident models and what sets each one apart
  •     Root cause, contributing cause, proximal cause: Clarifying confusion
  •     Why ‘human error’ is not a valid root cause
  •     Relationship of root/contributing/proximal causes to corrections/corrective actions
  •     A model to illustrate multiple layers of control and mitigation
  •     The four audiences of investigation reports: What each expects manufacturers to show
  •     The sections of an investigation report: What each must include
  •     What to do when a definitive root cause cannot be identified
  •     Investigation report with deficiencies: Ways to improve
  •     And much more!

This course comes with a ton of valuable working materials — charts, guides, reading lists, FDA regs/guidances/manuals, recent Forms 483 with pitfalls to avoid.

Conference Details
Conducting Advanced Root Cause Analysis CAPA Investigations:
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by FDAnews and Learning Plus**
Oct. 23-24, 2017 – Arlington, VA
http://www.fdanews.com/capapc

Tuition:
Early Bird Pricing: $1,697 (available until Sept. 22, 2017)
Regular Pricing: $1,897 (after Sept. 22, 2017)
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/capapc
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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