Vendor and Contract Supplier Qualification
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Who Should Attend
This course has been designed for those who need to
implement or improve their involvement in the relationship
between customers and suppliers to the pharmaceutical and
related industries. It will be of particular interest to appropriate
persons in:
• Corporate & Plant Management
• Purchasing
• Scheduling
• Materials Management
• Manufacturing
• Packaging
• Engineering
• Distribution/Warehousing
• Regulatory Affairs
• QA/QC
While the examples discussed are drawn mainly from the
pharmaceutical industry, the material has applicability to other
industries such as the biological, device, diagnostics and
cosmetics industries.
Description
From both a regulatory and business perspective, firms
should partner with their suppliers (both vendors & contract
suppliers) to assure that they receive materials and services
according to predetermined specifications for quality, quantity
& delivery. Some firms limit this activity to some degree of
“qualification” while others extend it to “certification” or
some form of “strategic alliance”. The topic is still evolving
particularly in the areas of shipping validation and the efforts
being made to combat the global growth of counterfeiting and
careless or purposeful adulteration of supplies.
This course reviews the regulatory and operational aspects
including the role of the quality and operations functions. It
includes reviews of the techniques by which customers &
suppliers can monitor one another by such methods as
statistical analysis and auditing. The role of the effect of FDA
inspections is reviewed and particular attention is given to the
problems presented by outsourcing including the need to
define respective customer and supplier responsibilities in
much detail.
The course includes hands-on workshops in which mini-teams
analyze case studies and present their findings.