Vendor and Contract Supplier Qualification
February 23 - 25, 2009
Amsterdam, The Netherlands
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This course is available as a client site course. Please click here for more information.
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
• 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 miniteams
analyze case studies and present their findings.