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.
WHY SHOULD YOU ATTEND
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. The purpose of this training is to provide you with an overview of the Technology Transfer process
At the end of the session, you should be able to:Define technology transfer processIdentify elements of the business process framework for managing technology transfersIdentify New Product transfer processExplain benefits of technology transfer and technology transfer guidelinesDetermine elements of a successful technology transfer
Technology Transfer principles discussed include
The importance of technology transferThe use of a technical review system to update and review technology knowledge obtained during drug product developmentThe use of a Product Strategy Review system to review important business aspects in preparation for transferTools and Templates used for technology transfer
This presentation will introduce the concepts associated with implementinga carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation.
WHO WILL BENEFIT
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:
Senior quality managers
Senior development managers
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