Course offering number:0812-202
Course ID:
1984
Vendor and Contract Supplier Qualification
December 8-10, 2008
New Brunswick, NJ
Who Should Attend
This course has been designed for those who need to
understand and improve their customer/supplier relationships.
It is of particular interest to appropriate persons in-
Corporate and Plant Management
- Materials Management
- Manufacturing
- Engineering
- Regulatory Affairs
- Purchasing
- Scheduling
- Packaging
- Distribution
- 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.
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.