Conducting Bulletproof CAPA Investigations — ADVANCEDUnderstanding Advanced Critical Thinking Skills and Innovative Techniques to Improve the Quality of Investigations and Understanding the Root Cause


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 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 2013.

NEW for 2013

In this year’s 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’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 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 during 8 interactive exercises

Space Is Limited — Register Today!

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
  • 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

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 valuable articles on CAPA
  • FDA field alert; MDR, BPDR, AE forms
  • FDA recall guidance
  • How to write an executive summary
  • Fishbone cause and effect diagrams
  • Tips on documenting/presenting root causes
  • Preventive action flowchart
  • Sample interview forms
  • Sample audit "checklists"
  • CAPA checklist
  • Mock failure investigation reports
  • Sample investigation plan
  • Sample case review form
  • Tips on conducting out-of-specification investigations
  • Compliance tips/best practices

Read Rave Reviews from Past Attendees

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 31 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 12 years (2000–2012).

To reserve your room, call the hotel at the number below. Be sure to tell the hotel you’re with the FDAnews workshop to qualify for the reduced rate. Only reservations made by the reservation cutoff date are offered the special rates, and space is limited. Hotels may run out of discounted rates before the reservation cutoff date. The discounted rate is also available two nights before and after the event based on availability. Hotel may require first night’s room deposit with tax. Room cancellations within 72 hours of the date of arrival or “no-shows” will be charged for the first night’s room with tax.

Sept. 10-11, 2013
Chicago Marriott Schaumburg
50 N. Martingale Road
Schaumburg, IL 60173
Toll Free: (800) 228-9290
+1 (847) 840-0100
Room rate: $149.00 plus 14 percent tax
Reservation cut-off date: Aug. 12, 2013

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.

Regular Rate
One Registration

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

Significant tuition discounts are available for teams of two 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.

2-4 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 of 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.

Here's what previous attendees have to say:

“[Barbara’s] anecdotal stories brought the course material to life.”
— Steve Henderson, Quality Assurance, Shared Capabilities, Procter & Gamble Pharmaceuticals

“[Barbara] is able to present ‘dry’ topics both lively and interactive. Great use of real life examples.”
— Johanna Stamates, Director Office of Research Compliance, University of Miami

“Barbara is obviously very knowledgeable of the topic discussed. I loved all the personal stories that Barb told. I also like the fact that the conference was geared to all types of business, not just devices or clinical.”
— Becky McCuen, Process Engineer, Merck

“Great speaker! [Barbara] used language that is easy to understand and takes time to answer questions.”
— Gorana Lakic, QA Supervisor, Apotex, Inc.

“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