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 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... 3 weeks ago | 103 mins 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 3 months ago | 159 mins 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... 3 months ago | 134 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. 5 months ago | 116 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 ... 12 months ago | 115 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 6 months ago | 158 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” ... 4 years ago | 77 mins Identification of unknown extractables and leachables using mass spectrometry... Petra Booij, Investigator at GlaxoSmithKline & Dr Kyle D’Silva, Pharma & BioPharma Marketing Leader, Thermo Fisher Scientific Full Title: Identification of unknown extractables and leachables using mass spectrometry: Identification with confidence? Extractable and Leachable ... 2 years ago | 57 mins Extractables and Leachables Testing Using a Quality Risk Management Approach Dhaval Tapiawala, Principal Scientist at Pfizer and Dr. Dennis Jenke, Principal Consultant for Nelson Labs Presented by Dhaval Tapiawala, Principal Scientist at Pfizer • Understanding extractables and leachables for better adoption of single use systems • ... 2 years ago | 108 mins 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 ... 2 years ago | 127 mins Load more
