Welcome to NewPressRelease.com a free press release service. Publishing press releases for Public Relations never been easier. Just register (it's free and it takes less then a 1 minute) then use Submit Press Release. Our services aim to help you reach journalists and to improve visibility in search engine listings, so you can get the most publicity possible.

GlobalCompliancePanelto organize RAPS pre-approved webinar on “Bullet-Proof Closed-Loop CAPA”

Events & Concerts

(Free Press Release) 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”.GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing this webinar, which earns up to 1.5 RAC credits towards a participant's RAC recertification upon full completion, on October 31.

GlobalCompliancePanelto organize RAPS pre-approved webinar on “Bullet-Proof Closed-Loop CAPA”


      

 

Description: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

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Phone: 800-447-9407

 




GlobalCompliancePanelto organize RAPS pre-approved webinar on “Bullet-Proof Closed-Loop CAPA”

Source: Press Release

---------------------------

Disclaimer

If you have any questions regarding information in this press release, please contact the person listed as the Author or use the contact informations published in the press release. Please do not attempt to contact NewPressRelease.com. We are unable to assist you with any information regarding this release. NewPressRelease.com disclaims any content contained in this press release. Please see our complete Terms of Service disclaimer for more information.

All press release information on this site, including free press releases, is solely based on what our users submit. NewPressRelease.com disclaims that any right and responsibility for the information goes to the user who submit the press release. Some press release may be confusing without additional explanation. You should contact the provider with any questions about the information presented. In case some press release damages your benefits or violate your rights in any way, please contact us and we'll remove it immediately.


Copyright © 2008 - 2018 Free Press Release by NewPressRelease.com