GlobalCompliancePanelto organize RAPS pre-approved webinar on "Bullet-Proof Closed-Loop CAPA
John E. Lincoln, a medical device and Regulatory Affairs consultant, will be the speaker at a RAPS pre-approved webinar on the topic, "Bullet-Proof Closed-Loop CAPA".
- Wilmington, NC (1888PressRelease) October 31, 2012 - CAPA,one of the four key inputs of the FDA's Quality Systems Inspection Technique (QSIT), is a major element of cGMP compliance. Having a tight, "closed-loop" CAPA systemthat addresses not the symptoms, but the cause, is good not only from the regulatory perspective; but to also ensure that your product consistently meets quality standards.
This webinar will offer ways by which to instill a sound CAPA system that will both meet regulatory expectations and help your business achieve its goals. It will collate CAPA with related tools of Failure Investigation and Root Cause Analysis, which lie at the heart of product complaint, non-conformance, and OOS failure investigations, and hazard analysis/risk management and mitigation activities.
Attendees of this webinar will become familiar with the nuances of a "closed loop" or "bullet proof" CAPA system. This webinar helps participants make sense of the vast amounts spent on quality/cGMP. It will give them insights into proper up-front risk-based, closed-loop CAPA, which is an integral part of viable Quality Management / cGMP planning, implementation and execution systems.
Areas Covered in the Session:
o Regulatory "Hot Buttons"
o CAPA Background
o Correction, Corrective Action, Preventive Action Defined
o Impact Analysis and Response - a Key Component
o CAPA System Assessment
o "Bullet-Proof"
o Data Sources / Metrics
o Monitor for Effectiveness
o "Closed-Loop" - Lock In the Change
o Beyond Regulatory Compliance
When:October 31, 10:00 AM PDT | 01:00 PM EDT
By whom:
John E. Lincoln, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.
For whom:
The webinar will benefit
o Senior Management in Drugs, Devices, Biologics, Dietary Supplements
o QA
o RA
o R&D
o Engineering
o Production
o Operations
o Consultants
Duration:90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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