Setting Up and Running a Tougher Supplier Audit Program

Venue: online webinar USA

Location: Fullerton, California, United States

Event Date/Time: Jan 20, 2010 End Date/Time: Jan 20, 2010
Registration Date: Jan 19, 2010
Early Registration Date: Jan 19, 2010
Abstract Submission Date: Jan 18, 2010
Paper Submission Date: Jan 18, 2010
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The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile medicine recalls, food chain problems and contamination, import problems, resignations.

Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.

Most Warning Letters will not have an initial judicial review, resulting in more and faster Warning Letter filings. Larger, higher profile companies are coming under FDA investigation activities. A key area gaining attention is 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. Getting supplier buy-in. Coping with "rogue" suppliers.

Areas Covered in the Session:

* Regulatory "Hot Buttons"
* Classify suppliers
* Supplier requirements by "classification"
* The site audit
* Types of remote audits
* Maintaining the relationship


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