Conference Description:
There is a pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events seem to support this perception. The FDA is working hard to change that perception. 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
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
Start Date: 2012-02-22
Last Day: 2012-02-22
Contact Person: webinars
Email: webinars@globalcompliancepanel.com
Address:
online training, Wilmington, DE, 19801, United States
Tel: 8004479407
Fax: 3022886884
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