Live Webinar
on
CAPA Challenges and FDA Expectations
Date & Time: Wednesday, July 27, 2011
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
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Instructor Profile:
Why you should attend:
John E Lincoln Consultant, Medical device and Regulatory Affairs
Expectations for meaningful, results driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies worldwide, with good reason. EU’s ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system utilizes root cause analysis for true problem (not symptom) resolution. Growing highprofile field problems indicate that effective "closed loop" CAPA is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA, an integral part of viable Quality Management / cGMP planning, implementation and execution systems.
Areas Covered in the Session:
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Regulatory "Hot Buttons" CAPA Background Correction, Corrective Action, Preventive Action Defined Impact Analysis and Response - a Key Component CAPA System Assessment Data Sources / Metrics Monitor for Effectiveness Lock In the Change - Close the Loop Beyond Regulatory Compliance
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peerreviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more
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