Course offering number:1005-204
Course ID:
2387
Assuring Quality of Supplies to Pharmaceutical and Related Industries
May 11-13, 2010
New Brunswick, NJ
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. It will be of particular interest to
appropriate persons in:
• Corporate & Plant Management
• Packaging
• Purchasing
• Engineering
• Scheduling
• Distribution/Warehousing
• Materials Management
• Regulatory Affairs
• Manufacturing
• 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 regulatory and business perspectives, firms in the
pharmaceutical & related industries should partner with their
suppliers (i.e. commodity suppliers and suppliers of services and
custom made materials) to assure that the firms 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 (1) shipping validation (2) supply chain
management under ambient and cold chain conditions (3) the
efforts being made to combat the global growth of counterfeiting
and adulteration of supplies and (4) applying a risk-based
approach to supplier qualification and monitoring.
This three-day, intensive course reviews the regulatory and
operational aspects including the role of 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 question/answer sessions and the last day is
devoted to discussing special problems associated with handling
ingredients and their suppliers.