Extractables and Leachables Testing Using a Quality Risk Management Approach
09th September 2020 | 10:00 am EST | Dhaval Tapiawala, Principal Scientist at Pfizer |BOOK FREE SEAT FOR THIS WEBINAR
• Understanding extractables and leachables for better adoption of single use systems
• Ensuring safety of drug through determining the level of leachables throughout product life cycle
• Case Study of implementation of standardized testing protocol
Presented by Dhaval Tapiawala, Principal Scientist at Pfizer
Dhaval graduated from University of Pune, India with B.E. in Chemical engineering in 1997. He joined University of Louisville in 1998 and completed his M.S. in Chemical engineering in 2000. His research thesis was increasing single cell protein from distillery waste. He has over 18+ years of experience in biotech industry. He has worked in validation group doing process & equipment validation, engineering group to design, technology transfer and CMC filing of therapeutic, blood plasma and vaccine processes. He has both upstream & downstream experience in microbial and cell culture platforms. In 2016, he joined Pfizer as Principal Technology Scientist to design brown-field capital project to technical transfer of commercial vaccine production to Pfizer site. He has vast experience of designing & implementing single use system in mainstream manufacturing and actively involved in BPOG.