Pharmaceutical Technology Transfer and Regulatory Strategies

This 2-day intensive, accredited course will provide a basic understanding of the technology transfer of analytical methods, active pharmaceutical ingredients, quality control standards, packaging components/operations and various pharmaceutical dosage forms from R&D to manufacturing. It is designed to provide an understanding of the issues affecting transfers within and outside a company. Topics will include transfers to/from international sites as well as to/from third parties. This course will also provide an overview of relevant FDA and ICH regulatory guidance documents including the Scale-up and Post Approval Changes (SUPAC) guidances documents and the Changes to an Approved NDA or ANDA Guidance. The issues affecting changes to the batch size, formulation, packaging components, site of manufacture, manufacturing process, analytical methods, specifications and processing equipment changes will be addressed. Speakers will use practical examples to highlight issues critical to successful technology transfer. Interactive case studies based on real examples will allow participants to develop strategies and plans in a team environment.