Education Sessions
The Position of Science in Technology Transfer (203)
| 28 October 08.15-11.30 | Track: Innovation |
ISPE CEUs: 0.2
(PDF Current as of 9 October 2008)
Review implications to traditional tech transfer, which PQLI introduces. QbD development will lead to an increased body of knowledge earlier in a product’s or process’s development. This knowledge needs to be efficiently transferred and manufacturing will need to apply this knowledge to further develop/improve the process/product. This puts additional requirements into the technology transfer process. Integration of new technologies and the expansion of process knowledge can aid in this process.
How You Will Benefit
At the end of this session, participants will be able to:
- Identify issues related to PQLI and tech transfer, and discuss possible solutions
- Develop a case for revisions to traditional tech transfer approaches based on new body of process/product knowledge
- Understand how data and new technologies can aid in this arena
Technical Documents - www.ISPE.org/publications
ISPE Good Practice Guide: Technology Transfer
Who Should Attend
Development and manufacturing scientists and engineers, and quality assurance professionals
ISPE Communities of Practice (COPs)
Active Pharmaceutical Ingredients (API), Biotechnology (Biotech), Good Automated Manufacturing Practice (GAMP), Process Analytical Technology (PAT), and Process/Product Development (PPD)
Session Leader
- James Blackwell, Senior Consultant, BioProcess Tech Consultants Inc, USA
Session Speakers
- Sheila Magil, Consultant, BioProcess Technology Consultants, USA
- Angel Morales, Pharma Chemist, Eli Lilly & Co, USA
- Gregory Needham, Research Scientist, Eli Lilly & Co, USA
- Seth Rodgers, CTO, BioProcessors, USA