FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC

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

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CAPA Workshop

CAPA Workshop

“I loved this course. [I] learned so much, and the take-home materials are great and can be used to train employees. I will highly recommend this course to others.” — Kate Garrido, Millennium Pharmaceuticals

Falls Church, VA (PRWEB) July 30, 2014

Conducting Advanced Root Cause Analysis CAPA Investigations
Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations
**Presented by Immel Resources and FDAnews**
Sept. 17-18, 2014 – Raleigh, NC
http://www.fdanews.com/CAPAWorkshopRaleigh

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 Immel Resources 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:
Barbara K. Immel, a published author and nationally known speaker, is president of Immel Resources LLC and editor of the Immel Report. She has 30 years of industry experience working in corporate quality assurance, compliance, training, documentation and labeling. Barb’s experience includes more than 12 years with Syva Company, Chiron Corporation and Syntex Corporation. Barb is the chairperson of the Annual FDA Inspections Summit hosted by FDAnews and a member of the steering committee for FDA MedCon 2010, Xavier University’s new medical device conference. Barb has been teaching well-respected courses on writing reports for deviations and failure investigations, and on conducting CAPA investigations, for the past 13 years (2000–2013).

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 Immel Resources and FDAnews**
Sept. 17-18, 2014 – Raleigh, NC
http://www.fdanews.com/CAPAWorkshopRaleigh

Tuition: $1,897
Significant team discounts are available.

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