2018 - Understanding and Implementing a Technology Transfer Process

OVERVIEW
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 implementinga 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:
o Define technology transfer process
o Identify elements of the business process framework for managing technology transfers
o Identify New Product transfer process
o Explain benefits of technology transfer and technology transfer guidelines
o Determine elements of a successful technology transfer
AREAS COVERED
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
• Tools and Templates used for technology transfer
LEARNING OBJECTIVES
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
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Process owners
• Quality engineers
• Quality auditors
• Development professionals
• Senior development managers
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