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 you should Attend:
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
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
Who Will Benefit:
- 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