Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems. This presentation will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation.
Areas Covered in the Seminar or Webinar:
Technology Transfer principles discussed include
The importance of technology transfer
The use of a technical review system to update and review technology knowledge obtained during drug product development
The use of a Product Strategy Review system to review important business aspects in preparation for transfer