Live Webinar
on
Implement a Tougher Supplier Audit Program
Date & Time: Wednesday, February 22, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: John E Lincoln
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
John E Lincoln Consultant, Medical device and Regulatory Affairs
This webinar will discuss and evaluate the effects that this call for change has on a company and its selection, audit, use and on-going relations with its suppliers of services and products / components. What are the "new" expectations for the COA and COC? How can companies address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? Expectations for meaningful, results driven actions that addresses and resolve any underlying compliance issues or product problems are increasing among regulatory agencies worldwide. To meet the new regulatory climate and be competitive, companies need to reevaluate their vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners".
Areas Covered in the Session: l l l l l l
Regulatory supplier "Hot Buttons" Classify suppliers; Supplier requirements by "classification" What's behind the COA? The COC? The FDA's increasing emphasis on the site audit Types of remote audits Entropy, and maintaining the relationship
Click here to register for this webinar Who Will Benefit: l
Senior management in Drugs, Devices, Biologics, Dietary Supplements
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QA RA R&D
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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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