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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.
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But creating an FDA-proof CAPA isn't easy.
If only you 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, you can.
FDAnews and Immel Resources are offering an advanced version of our 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, you will:
- Learn how to respond to the FDA and implement effective CAPAs toprevent 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, manualsand guidance.
- Interact with colleagues during 8 exercises.
Additional benefits you'll receive when you attend the Conducting ADVANCED Root Cause Analysis and CAPA Investigations include:
- Gain valuable strategies for performing in-depth interviews anddetermining individuals responsible for an event.
- Discover best practices for training, assigning and managing yourlead investigators, using proven law enforcement techniques.
- Benchmark current best practices in CAPA and investigations withyour 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, medicaldevice 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.
Register today for this intensive hands-on training workshop if you are a:
- 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
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 DETAILSConducting Advanced Root Cause Analysis and CAPA Investigations:Understanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations**Presented by Immel Resources and FDAnews**May 21-22, 2014 – Schaumburg, ILwww.fdanews.com/CAPAChicago
TUITION: $1,897 per attendee
Easy Ways to RegisterOnline: www.fdanews.com/CAPAChicago 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.
Media Contact: Michelle Butler, FDAnews, 703-538-7665, [email protected]
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SOURCE FDAnews
