FDAnews Announces: Conducting Advanced Root Cause Analysis CAPA Investigations, Feb. 24-25, 2016, Raleigh, NC

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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**
Feb. 24-25, 2016 – Raleigh, NC
http://www.fdanews.com/capapc

Inadequate investigations and CAPAs have been one of the top reasons for 483 observations since 1997.

The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important.

But creating an FDA-proof investigation and CAPA isn’t easy.

What if manufacturers could talk with an industry leader who has spent years reading investigation reports, studying human error and performance issues, facilitating training sessions around the world, helping firms under consent decrees, and establishing investigation programs?

Well, they can.

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.

In this year’s Conducting Advanced Root Cause Analysis and CAPA Investigations workshop, attendees will:

  • Learn how to conduct an effective, efficient investigation to avoid regulatory action and get a favorable closeout letter.
  • Discuss lessons learned from recent FDA warning letter citations on CAPA investigations.
  • Learn key problem-solving techniques to break a problem down into its component parts: Change Analysis, Fishbone Diagrams and Fault Trees.
  • Receive a course workbook complete with charts, forms, manuals and guidance.
  • Interact with colleagues during 12 interactive activities.

Additional benefits attendees will receive by attending the Conducting Advanced Root Cause Analysis and CAPA Investigations include:

  • Gain valuable strategies for getting information right away in the “golden hours” after the incident.
  • Discover best practices for determining the real cause of human error with tools used by aviation accident investigators.
  • Benchmark current best practices in CAPA and investigations.
  • Learn practical strategies and techniques.
  • Obtain sample forms for conducting investigations and case reviews.
  • Demonstrate the value of a cross-functional team and also ways that experts demonstrate their expertise
  • Understand the four elements of a well-written report and how to coach employees on report writing.

Who Will Benefit:

  • CAPA manager
  • QA/QC managers and director
  • Compliance officer
  • Training manager
  • GCP, GLP or GMP professional
  • Regulatory affairs manager
  • Quality engineer
  • Anyone wishing to improve an organization's CAPA activities and investigations

Meet the Instructor:
James Vesper, President, LearningPlus, Inc. — James Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He is founder and president of the firm LearningPlus, and has had more than 30 years' experience in the pharmaceutical industry, including 11 years at Eli Lilly. Since 1991, Mr. Vesper has been creating innovative instructional training products for the pharmaceutical and healthcare industries using video and computer technologies as more effective and efficient delivery media. Working as a consultant with a wide variety of clients, his firm creates integrated curricula for personnel and customized training courses targeted to specific needs. He presents papers and workshops at various international technical and professional meetings, including those of the International Society for Pharmaceutical Engineering, GMP TEA, PDA, Pharmaceutical Sciences Group and PharmTech.

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**
Feb. 24-25, 2016 – Raleigh, NC
http://www.fdanews.com/capapc

Tuition: $1,897
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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