This training 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. It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge.
At the end of the session, you should be able to:
Define technology transfer
Identify elements of the business process framework for managing technology transfers
Identify New Product transfer process
Explain benefits of technology transfer
Determine elements of a successful technology transfer
Why You Should Attend:
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.
Areas Covered in the Session :
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
Interactive Q&A Session
Who Will Benefit:
Quality Departments
Regulatory Affairs Departments
Compliance Departments
Production Departments
Manufacturing Departments
Process Owners
Development Departments