Overview: The US FDA has discovered that a reasonably large number of recalls and adverse events are related to supplied product.
Medical device supplier activities is now a focus area for FDA inspections and also third party audits. This concern is now reflected internationally with the publication of a GHTF guidance document on supplier activities. This increased focus by regulators on supplier activities should cause medical device companies to review their processes against requirements to avoid audit and inspection findings.
Areas Covered in the Session:
Supplier Controls reduce supplier problems
Supplier evaluation techniques lead to selection of better suppliers
Supplier selection processes must be effective in choosing the right suppliers
Acceptable Supplier Listings are used to show what products suppliers can efficiently provide
Removing suppliers from Acceptable Lists when there are issues
Impact of Risk Management on Supplier processes
How to develop a Supplier Management process that meets regulators expectations.