Conducting Bulletproof CAPA Investigations — ADVANCED

$1,897.00
The FDA's new enforcement plan makes one thing clear: Developing a successful CAPA program has never been more important.

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



Click here to view the brochure!

 



Click here to view the agenda.

Your valuable course materials book is packed with tools and reference data you can put to use right away, including:

  • FMEA chart
  • How to respond to FDA Form 483s and warning letters
  • Comprehensive CAPA bibliography and recommended reading list
  • Current FDA regulations
  • Pertinent guidance documents
  • Three articles on problem investigations
  • FDA inspection manuals
  • FDA's out-of-specification guidance
  • ICH E6 good clinical practice guidance
  • Recent FDA Form 483s or EIRs
  • Pertinent FDA warning letters
  • 16 great interviewing tips
  • Two articles on CAPA
  • FDA field alert, MDR, BPDR, AE forms
  • FDA recall guidance
  • Writing an executive summary
  • Fishbone cause and effect diagrams
  • Tips on documenting/presenting root causes
  • Preventive action flowchart
  • Sample interview forms
  • Sample audit "checklists"
  • Writer's questionnaire
  • Speaker's questionnaire
  • On customer complaints
  • CAPA checklist
  • Mock failure investigation reports
  • Sample investigation plan
  • Sample case review form
  • Tips on conducting out-of-specification investigations
  • Compliance tips/best practices

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

Register today for this intensive hands-on training workshop if your responsibilities include:

  • CAPA managers
  • QA/QC managers and directors
  • Compliance officers
  • Training managers
  • GCP, GLP or GMP professionals
  • Regulatory affairs managers
  • Quality engineers
  • 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 28 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 chairwoman of the Annual FDA Inspections Summit hosted by FDAnews. Barb has been teaching well-respected courses on writing reports for deviations and failure investigations and on conducting CAPA investigations for the past 9 years (2000–2009).

 

Sept. 29–30, 2010
Conrad San Juan Condado Plaza
999 Ashford Ave.
San Juan, PR 00907
Toll Free: (888) 722-1274
Telephone: +1 (787) 721-1000
Fax: +1 (787) 722-7955
www.condadoplaza.com
$109.00 plus 11% tax, plus 14% resort fee per night
Cutoff: Sept. 7, 2010

Register Early — Space is Limited
Hurry — register early because space is limited! Your tuition of $1,897 per attendee includes the two-day workshop, all conference materials, continental breakfast and lunch each day.

Send Your Team for Maximum Benefit
Get your team up to speed!

Significant tuition discounts are available for teams of three or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

 

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions
Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.