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.

Sponsored by Nelson Labs

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.

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