Process Validation

  
    Due to the complexity of today's medical products, routine end-product testing alone often is not sufficient to assure product quality for several reasons. Some end-product tests have limited sensitivity.  In some cases, destructive testing would be required to show that the manufacturing process was adequate, and in other situations end-product testing does not reveal all variations that may occur in the product that may impact on safety and effectiveness.  For this reason, process must be validated.  This course covers process validation from first principles through the actual generation of the protocols. 
  • We offer training on all aspects of Process Validation with  typical course covering the following topics;-
  • Determining critical parameters, variable and fixed (risk assessment)
  • Equipment and Process
  • Equipment : Installation Qualification and Operational Qualification
  • Product: Optimization
  • Product: Performance Qualification
  • When is revalidation required
  • How to compile the appropriate documentation
  • Validation review and when is more validation needed

To gain an overview of the above subjects will take one day however, training can be tailored to the needs and capabilities of the organisation with more in-depth training being provided if required.