Assuring Quality of Supplies to Pharmaceutical and Related Industries

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.