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This two-day course focuses on the processes associated with the acquisition of products, materials and services that fuel and support the organization’s product manufacturing and marketing. These cross-functional processes are complex and result in conflicting objectives between decision-makers. Management is responsible for organizing and providing resources and the more they understand, the more effectively they can manage. This course begins with a discussion about quality and compliance and some of the regulations pertinent to supplier/contractor qualification and control. The primary regulations are: – Part 211, Subpart E-Control of Components and Drug Product Containers and Closures, ICH Q7A, Section VII, Materials Management Part 820, Subpart F, Purchasing Controls. – ISO 13485:2016, ISO 9001:2015, pertinent ICH & IMDRF (formerly GHTF) documents and pertinent FDA guidance documents. Quality concepts from quality gurus will also be presented. – Contract Testing Laboratories – Part 58, Good Laboratory Practices, (GLP) contractors. Who Should Attend:
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