Search results Search for: Search Refine your results by duration: Any Under 5 mins Under 20 mins Over 20 mins Sort by: Relevance Views Date Safety Evaluation on Extractables and Leachable Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals October 25, 2022 2:00pm Handling mutagenic extractable and leachable compounds released from devices Ron Brown, Toxicologist at Risk Science Consortium and Piet Christieans, PhD, Scientific Director at Nelson Labs Genotoxic compounds can be released from some medical devices during their clinical use. The ISO 10993-17:2002 standard outlines steps to assess the ... 5 months ago | 115 mins An impurity detected in a stability study... Petra Booij, Investigator bij GlaxoSmithKline and Ward D’Autry, PhD Study Director at Nelson Labs Europe Full Title: An impurity detected in a stability study: Did we miss anything in our E&L risk assessment? Extractable and leachable (E&L) testing are r... 3 months ago | 90 mins Mass Transport Modelling in support of leachable risk management. Thomas Egert at Boehringer Ingelheim Pharma and Jason Creasey at Maven E&L Ltd Leachable risk management continues to be of regulatory interest. However we continue to rely on experimental extractable studies as predictors of lea... January 17, 2023 3:00pm Latest Analytical Techniques in Extractable and Leachables Dr. Tom van Wijk, Abbott Healthcare Products BV In contrast to other impurities the control of extractable and leachables is not well defined yet. Currently guidance is provided e.g. by USP and PQRI... 1 year ago | 70 mins The Importance of Accurate Chemical Characterization of Medical Devices... Ron Brown, Toxicologist at Risk Science Consortium and Piet Christiaens, PhD, Scientific Director at Nelson Labs Full title: The Importance of Accurate Chemical Characterization of Medical Devices Extractables November 16, 2022 3:00pm Risk Assessment of Extractables and Leachables... Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals Full title: Risk Assessment of Extractables and Leachables in Different Phases of Development. As the knowledge on the manufacturing process evolves ... 1 year ago | 127 mins Future Trends To Control Risks From Extractables and Leachables Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Kathleen Lava PhD – E&L Expert Nelson Labs Europe Presented by Jason Creasey, Managing Director at Maven E&L Ltd Jason Creasey is a graduate Analytical Chemist. He has recently setup as an independen... 1 year ago | 105 mins Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachab Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol Presented b... 2 years ago | 88 mins Extractables and Leachables have been used interchangeablely for too long. Are w Ken Wong, Deputy Director at Sanofi Pasteur and Don DeCou, Extractable and Leachable Technology Manager at West Pharma Extractables and Leachables have been used interchangeablely for too long. Are we still confused? The terminologies of “Extractable” and “Leachable” ... 3 years ago | 77 mins Load more
