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Implement a Tougher Supplier Audit Program - Webinar By GlobalCompliancePanel

  January 05, 2012  
GlobalCompliancePanel, Online Training

Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. 

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".

Why you should attend: The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. The commissioner vows no more "business as usual".  Data in cGMP records must be more science based. Companies are outsourcing more; with some thinking they can also outsource some of their cGMP compliance as well. Thus, the FDA has indicated that a key area they are focusing attention is on a company's suppliers, for both services and products / components. Why needed?  FDA expectations? How are successful companies meeting this challenge. Tools that need to be put in place or enhanced. The required supporting infrastructure for COAs and COCs. Meeting the challenges of more "on site" audits. Getting supplier buy-in. Coping with "rogue" suppliers.

Areas Covered in the Session:
  • 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
Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements 
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

Organized by: GlobalCompliancePanel
Invited Speakers:
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 peer-reviewed 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 FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Deadline for Abstracts: 2012-02-21

Phone: 800-447-9407
Fax: 302-288-6884
E-mail: globalcompliancepanel@gmail.com
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