Pharmaceutical Technology Transfer and Post-Approval Changes

Who Should Attend?

This course is intended for individuals from:

  • Formulation and Process Development/Validation
  • Regulatory Affairs, QA, QC
  • Analytical Methods Development
  • Package Development/Engineering
  • Manufacturing and Technical Support
  • Project Management and Planning

Participants will benefit by gaining a better understanding of the complexities of technology transfer of various dosage forms in the pharmaceutical industry.


Course Description

This 15-day intensive, accredited course will provide a basic understanding of the technology transfer of analytical methods, 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 the transfer within and outside a company. Topics will include transfer of technology to/from international sites as well as to/from third parties. In addition, this course will also provide an understanding of the FDA Scale-up and Post Approval Changes Guidelines & the 2004 FDA guideline on changes to an approved NDA or ANDA. The issues affecting batch size scale-up/scale-down, various post approval formulation component or composition changes, site of manufacturing changes, manufacturing process changes, and equipment changes will be addressed along with the issues affecting analytical methodology, packaging and labeling changes. Most of all, the Speakers will use practical examples to highlight issues critical to successful technology transfer in compliance with FDA regulations.

Furthermore, Interactive case studies based on real examples will allow participants to develop strategies and plans in a team environment.