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, at Bayer AG, R&D Pharmaceuticals and Tino Otte at Intertek Presented by Dr Clemens Günther, Senior Expert Nonclinical Safety, Director at Bayer AG, R&D Pharmaceuticals 8 months ago | 159 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... 5 months ago | 103 mins Insights into Practical Issues Associated with Extractables Testing... Dennis Jenke, Chief Executive Scientist at Triad Scientific Solutions Full title: Insights into Practical Issues Associated with Extractables Testing of Medical Devices It is a well-known adage that “the devil is in the... December 5, 2023 3:00pm How Digitization Can Improve Bioprocessing and Make Manufacturing More Robust Charlotte Masy at GSK Vaccines and Sara Jane Bresee at MasterControl Presented by Charlotte Masy, Senior Manager in Manufacturing Science and Technology GSK Vaccines and Sara Jane Bresee, Managing Director of APAC at Ma... September 25, 2023 2:00pm Ruggedness and Robustness in Nitrosamine Analysis from Pharmaceutical Elastomers Jason Creasey, at Maven E&L Ltd and Ank Reumer, at Nelson Labs Presented by Jason Creasey, Managing Director at Maven E&L Ltd and Ank Reumer, Senior Study Director, Quantitative Methods Team at Nelson Labs This w... September 4, 2023 2:00pm The Importance of Accurate Chemical Characterization of Medical Devices... Ron Brown, Toxicologist at Risk Science Consortium and Dries Cardoen, PhD, Sr. E&L Expert – Team leader at Nelson Labs Full title: The Importance of Accurate Chemical Characterization of Medical Devices Extractables Chemical characterization of medical devices, involv... 7 months ago | 134 mins 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 ... 1 year ago | 115 mins 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... 2 years ago | 70 mins ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables... Jason Creasey at Maven E&L Ltd, and Philippe Verlinde at Nelson Labs Full title: ICH Q3E Impurity Guidelines: Assessment and Control of Extractractables and Leachables for Pharmaceuticals and Biologics. 9 months ago | 116 mins Challenges In Therapeutic Biological Products Paolo Grisostomi at Biogen, Donald Young Thermo Fisher Scientific and Dr. Sona Kovackova at Nelson Labs Europe Presented by Paolo Grisostomi, Senior Engineer, Materials Science at Biogen and Donald Young, Sr. Product Manager at Thermo Fisher Scientific 10 months ago | 158 mins Load more
