June 29, 2006 — /MEDICAL INDUSTRY E-MAIL NEWS SERVICE(TM)/ — FALLS CHURCH VA USA — FDAnews & Immel Resources announced details today of 2 CAPA seminars, Sept 27-29 2006 in Boston MA, and Oct 11-13 2006 in Raleigh NC.

BACKGROUND:

CAPA systems are an area of intense FDA scrutiny. More than 50% of Form 483 observations and warning letters cite CAPA deficiencies. When FDA inspectors identify problems with a CAPA system, they will inevitably target the organization’s entire quality audit system.

“Here’s the intensive CAPA training you’ve been looking for. There’s no fluff and theory in this workshop. You’ll roll up your sleeves to dig into 2 1/2 days of skill building interactive exercises, case studies, small group discussions and mock presentations,” says Jeff Grizzel, Conference Director.

Gain critical investigation techniques in this 2 1/2 day skills-building workshop. Included are 5 interactive exercises, 2 case studies, a “pet peeves” group discussion, current events discussion of possible preventive action projects, a small group review of FDA inspection guides, and a mock presentation to practice and hone your skills.

WHAT YOU WILL LEARN:

Build CAPA investigation techniques to meet intense regulatory scrutiny in this hands-on, interactive workshop, where you will:

— Discover the most recent investigation trends, so you can anticipate expectations before it ends up in a Form 483
— Practice brainstorming techniques for root cause analyses
— Develop proven investigation techniques and strategies to measure effectiveness
— Explore best practices in out-of-specification (OOS) investigations and SOPs
— Learn strategies to manage CAPA systems, and key points to teach employees and peers
— Develop expert internal audit techniques, including clearly discussing critical findings
— Improve persuasion, negotiation and debating skills
— Analyze preventive action issues – the least understood and most neglected part of CAPA
— Better communicate potential risks to senior management – and help your organization take appropriate action

REGISTER TODAY FOR CONDUCTING BULLETPROOF CAPA INVESTIGATIONS AT:

http://www.fdanews.com/wbi/conferences/capaworkshop.html

MEET YOUR INSTRUCTORS:

Barbara K. Immel, a published author and nationally known speaker, is President of Immel Resources LLC, and editor of the Immel Report(TM). She has 24 years of industry experience, working in compliance and training, documentation and labeling, corporate quality assurance and marketing. Barb’s experience includes more than 12 years with Syva Co, Chiron Corp and Syntex Corp.

Barb has presented at hundreds of national and international industry meetings, and has taught well-respected GMP classes for 20 years. She has taught biotech and drug development courses for UC Berkeley Extension, served as an instructor for the Pharmaceutical & Biotechnology Quality Assurance Course for the University of Wisconsin, Madison, served as a panelist at the Stanford Professional Publishing Course, and recently taught a tutorial on FDA’s phase 1 proposals at the 30th Annual GMP Conference, University of Georgia.

WHO WILL BENEFIT:

— CAPA specialists
— Compliance information managers
— GMP compliance officers
— GMP training managers
— Heads of internal audits
— QA documentation managers
— QA/QC managers & directors
— Quality systems managers
— Regulatory affairs managers
— Systems analysts
— Training personnel

CONFERENCE DETAILS:

Conducting Bulletproof CAPA Investigations: Interactive Workshop on Investigating Techniques to Meet Regulatory Scrutiny

— Sept. 27-29, 2006 – Boston, MA
— Oct. 11-13, 2006 – Raleigh, NC
— Tuition: $1,890 per attendee

4 EASY WAYS TO REGISTER:

http://www.fdanews.com/wbi/conferences/capaworkshop.html

888-838-5578 phone
703-538-7600 phone
703-538-7676 fax

Mail To:

FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431

SATISFACTION GUARANTEED:

You must be 100% satisfied with this learning opportunity or we’ll refund your entire tuition, or extend a credit to a future FDAnews conference.

CANCELLATIONS/SUBSTITUTIONS:

Written cancellations received at least 1 week prior to the start date of the event will receive a 100% refund or credit toward a future FDAnews event. After that time, refunds will be subject to a $200 administration fee. Substitutions may be made at any time. No shows will be charged the full amount.

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.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Jeff Grizzel
Conference Director
FDAnews
300 N Washington St Ste 200
Falls Church VA USA 22046-3431
703-538-7600 phone
703-538-7676 fax
[email protected]