During this webinar our presenter will guide you through the best practices in drafting a technical and business governance program and also defining Research and Development for successfully implementing steps for site transfer. We will cover the best practices in transferring the scientific technology needed to manufacture the product, methods by which you could ensure the receiving manufacturing facility is ready for the product and tools and templates to assist in securing the observations.
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:
Transfer of pharmaceutical products and their processes is imperative for a successful launch. Successful transfer ensures that the best quality products are manufactured to meet the patient needs and also achieve the business goals of the company. Interactions of many disciplines across the organization are critical in executing the transfer. It depends on the precise development, management, and transfer of technical and business knowledge and also developing steps to define the proper transfer of that knowledge from Research and Development documents and systems to commercial manufacturing documents and system.
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 Should Attend:
- Quality Departments
- Regulatory Affairs Departments
- Compliance Departments
- Production Departments
- Manufacturing Departments
- Process Owners
- Development Departments
Course Director: STEVEN LAURENZ
Steven Laurenz, Principal Consultant – BioPhia Consulting Inc., has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization.
Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium.
Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University