FDAnews Announces: Conducting Advanced Root Cause Analysis and CAPA Investigations, Dec. 3-4, 2014, Tampa, FL

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The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important. FDAnews and Compliance Media, Inc. are offering an advanced version of their previous CAPA investigations class, fully updated to meet tough FDA scrutiny in 2014.

Conducting Advanced Root Cause Analysis and CAPA Investigations
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by FDAnews and Compliance Media, Inc.**
Dec. 3-4, 2014 – Tampa, FL
Save 10% With Promotion Code TAMPA2014 (enter code at checkout)
http://www.fdanews.com/CAPAWorkshopTampaSave10

CAPA has been the #1 reason 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 CAPA isn’t easy.

If only drug and devicemakers could pick the brain of someone who is coping successfully with CAPA, the best and the brightest, an industry leader who has devised programs, procedures and solutions that have put companies out in front with the FDA.

Well, they can.

FDAnews and Compliance Media, Inc. are offering an advanced version of their previous CAPA investigations class — fully updated to meet tough FDA scrutiny in 2014.

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

  •     Learn how to respond to the FDA and implement effective CAPAs to prevent regulatory action and get a closeout letter.
  •     Get an insider’s view of the FDA's own training program for investigators, with portions of the Reid Technique DVD reviewed during the course.
  •     Discuss lessons learned from nine years of FDA warning letter citations on CAPA investigations.
  •     Learn key problem-solving techniques to break a problem down into its component parts: CIA, Kepner-Tregoe and FMEA.
  •     Receive a course workbook complete with charts, forms, manuals and guidance.
  •     Interact with colleagues during 8 exercises.

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

  •     Gain valuable strategies for performing in-depth interviews and determining individuals responsible for an event.
  •     Discover best practices for training, assigning and managing your lead investigators, using proven law enforcement techniques.
  •     Benchmark current best practices in CAPA and investigations with your peers.
  •     Learn 22 great investigative tools you can teach to all your employees.
  •     Obtain sample forms for conducting investigations and case reviews.
  •     Review required FDA notifications, such as field alerts, medical device reports, biologic product deviation reports, adverse events, serious adverse events, recalls, corrections and removals.
  •     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

The Expert Instructor:
Gregory Meyer RAC, CQA is President and Principal Consultant and Trainer at Compliance Media, Inc. Mr. Meyer has been providing quality assurance, quality systems, and clinical regulatory guidance for biopharma and medical device companies for more than 20 years. He has conducted training for industry, regulators and academia and regularly presents at meetings of the Parenteral Drug Association, the American Society for Quality, and the Regulatory Affairs Professionals Society. He has held director level positions in biopharma, small molecule and medical device companies in quality, regulatory affairs, and compliance. His training production company, Compliance Media produced the video documentary FDA: A History for the U.S. Food and Drug Administration's Centennial in 2006 and he is a recognized expert in the history and operations of FDA, as well as ICH Guidance, ISO compliance, and GHTF standards for medical devices.

Conference Details
Conducting Advanced Root Cause Analysis and CAPA Investigations
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by FDAnews and Compliance Media, Inc.**
Dec. 3-4, 2014 – Tampa, FL
Save 10% with Promotion Code TAMPA2014 (enter code at checkout)
http://www.fdanews.com/CAPAWorkshopTampaSave10

Tuition:
Regular Tuition: $1,897
10% Savings Tuition: $1,707 (must use Promotion Code TAMPA2014 at checkout)
Significant team discounts are available.

Easy Ways to Register
Online: http://www.fdanews.com/CAPAWorkshopTampaSave10
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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