This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process.
Technology transfer of a cGMP pharmaceutical manufacturing process to an outsource/partner site is a significant undertaking, one that needs to be accomplished quickly and efficiently. The expertise of several functions at both the sending and receiving site must be employed and skillful integration of all of the relevant project components is required.
Areas Covered in the seminar:
This webinar will cover the essential aspects for the cGMP-compliant technology transfer of a pharmaceutical manufacturing process:
- Generation of essential site selection criteria
- Creation of an effective technology transfer team, with representatives of relevant functions within each organization
- Use of professional project management tools to ensure on-time and on-budget delivery
- Creation and tracking of all project documents to support effective technology transfer and to ensure cGMP compliance
- Integration of the sending and receiving site quality assurance systems
- Creation of validation master plans and protocols for utility systems, analytical procedures, process equipment and manufacturing processes
Who Will Benefit:
All personnel and managers involved with technology transfer from the following functions:
- Product, process and formulation development
- Project management
- Analytical development
- Manufacturing sciences
- Manufacturing
- Quality assurance
- Quality control
- Regulatory affairs
Instructor Profile
Rodney E. Thompson , Ph.D., the Founder and President of BioPharm Process Associates ( www.biopharmprocess.com ) , has 20 years of experience in the biopharmaceutical, vaccine and medical device industries. He specializes in the development of cost-effective, reproducible biotherapeutic and vaccine manufacturing processes; biopharmaceutical process design and process validation; the outsourcing and technology transfer of cGMP-compliant manufacturing technology; system validation and outsourcing contract negotiation. Dr. Thompson has led and contributed to numerous international technology transfer projects at cGMP compliant facilities in both small and large corporations. He has managed the process design and manufacturing implementation for eight different biotherapeutic products in the last 12 years.
Dr. Thompson regularly teaches courses in technology transfer, process validation and the cGMP production of clinical trial material and is a frequent presenter at industry conferences. Previously, he held Director-level positions in process development/manufacturing at Aviron, InSite Vision and Applied Immune Sciences, and performed biopurification process development/scale-up/technology transfer at Chiron, Xoma and Kodak Research. Dr. Thompson received a Ph.D. in chemical engineering from the University of California-Berkeley and graduated first in his class with a B.S. from the Cornell University School of Chemical Engineering.
