Vendor and Contract Supplier Qualification

Corporate and Plant Management
Purchasing
Materials Management
Scheduling
Manufacturing
Packaging
Engineering
Distribution
Regulatory Affairs
QA/QC

While the examples discussed are drawn mainly from the pharmaceutical industry, the material has applicability to other industries including the biological, device, diagnostics, and cosmetics industries.

Description:
From both a regulatory and business perspective, firms should partner with their suppliers (both vendors and contract suppliers) to assure that they receive materials and services according to predetermined specifications for quality, quantity and delivery. Some firms limit this activity to some degree of “qualification” while others extend it to “certification” or to some type of “strategic alliance.”

This course reviews the regulatory, legal and operational aspects including the role of the quality and operations functions. It includes a review of the techniques by which customers and suppliers can monitor one another via such techniques as statistical analysis and auditing. The FDA perspective, including the role and effect of FDA inspections, is reviewed, and particular attention is given to the problems involved in contract work (i.e. outsourcing), with an emphasis on the need for carefully defining the respective responsibilities of the customer and supplier. The course includes a hands-on workshop in which mini-teams analyze case studies and present their findings.