Conducting Bulletproof CAPA Investigations ADVANCED
Product Details
But creating an FDA-proof CAPA has never been 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 — designed to meet tough FDA scrutiny in 2010.
Space Is Limited — Register Today!
NEW for 2010! In the Conducting Bulletproof CAPA Investigations — ADVANCED Workshop, you will:
- Learn how to respond to the FDA and implement effective CAPA to prevent regulatory action and get a closeout letter
- Get an insider view of the FDA's own training program for investigators — portions of the Reid Technique DVD will be reviewed during the course
- Reviewing lessons learned from nine years of FDA warning letter citations on CAPA investigations
- Learn key problem-solving techniques to break down a problem into its component parts: CIA, Kepner-Tregoe and FMEA
- Receive a course workbook complete with charts, forms, manuals and guidance
- Interact with colleagues to participate in 14 interactive exercises
Additional benefits you'll receive when you attend the CAPA Workshop — ADVANCED include:
- Gain valuable strategies for performing in-depth interviews and determining individuals responsible for an event
- Using proven law enforcement techniques, discover best practices for training, assigning and managing your lead investigators
- 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
Your valuable course materials book is packed with tools and reference data you can put to use right away, including:
|
|
Here's what previous attendees have to say:
“Very thorough. Great real-life experiences. Enjoyed this course, the content and especially
Barbara. Her wealth of knowledge and presentation style welcomes all levels of personnel in an engaging environment.”
Charla Lee
Supervisor, Incident Team, Talecris Biotherapeutics
“Very, very knowledgeable in what she is teaching. Excellent presence! I liked the
group work and the interactions with others and their experiences.”
Jason Ferens
Quality Engineer, Fort Wayne Metals
“Barbara was very knowledgeable. The way the class was structured with the interactive
exercises, videos, etc. made the days go fast! I got a lot of useful information to bring back to my company. Talking to peers gave insight into other
company’s processes.”
Loren Jennings
Quality Systems Coordinator, Fujirebio Diagnostics
“Barbara is a great speaker, very knowledgeable and forthright in sharing and delivering
information. I liked the interactiveness of the workshop and the ability to meet and share information with people in other areas of industry.”
Michael Lippi
Senior Quality Management Engineer, Perceptive Informatics
“I very much enjoyed these classes. I will be using what I have learned to update our
CAPA system. You are a very good speaker and I would recommend you to other people.”
Lisa Reynolds
RA/PQA Coordinator, IPAS
“Wonderful job Barbara! You presented information that will be useful for improvement
of the CAPA program at our facility.”
Kathy May
QA Specialist, Metrics, Inc.
“Very pleased with
the workshop. Got a lot of insight and information that will be useful and practical on the job. Greatly enjoyed the interactive approach instead of a
completely instructor-led course.”
Justine Koor
Process Quality Management Engineer, Perceptive Informatics