Setting Up and Running a Tougher Supplier Audit Program
Venue: online webinar USA
|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|
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 companyâ€™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