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 Current USP Perspectives on a Rapid Sterility Test Dr David Roesti, Novartis/USP and Erin Patton, Charles River The current growth-based Sterility Tests with at least 14-days incubation is not suitable for short-lived products. An expert panel was formed under t... 5 years ago | 65 mins Application of USP 665 data to support qualification of single use systems Ken Wong of Sanofi Pasteur, Desmond G. Hunt, of USP and James Hathcock of Pall Biotech Application of USP 665 data to support qualification of single use systems Presented by Ken Wong, Desmond G. Hunt and James Hathcock This talk will... 3 years ago | 121 mins Breach Detection: Becoming as Agile as The Attackers U.S. Navy, U.S. Dept. of Transportation, U.S. Dept of Labor, USPS, Ponemon Institute, ATARC, Forcepoint Moving “left of breach” is the modern cybersecurity path forward that every agency should be striving for. That means focusing cybersecurity resources... 2 years ago | 63 mins Qualification of Raw Materials and Cell Substrates for Biomanufacturing Maura Kibbey Senior Scientific Fellow, Global Biologics at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck Presented by Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia Followed by an Industry Perspective presented by Mar... 3 years ago | 83 mins Transformation of Toxicology data into Specific PDE’s Kim Li, PhD, DABT, MPH, Amgen Inc and Dries Cardoen, Team Leader of Study Directors at Nelson Laboratories, LLC Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. Followed by an industry perspective presented by Dries Cardoen, Team Leader of Study Directors - Inha... 3 years ago | 92 mins Qualification of Raw Materials and Cell Substrates for Biomanufacturing Maura Kibbey Senior Scientific Fellow, Global Biologics at USP and Martin Wisher, Global Head of Regulatory Affairs at Merck Presented by Maura C. Kibbey, Ph.D., Senior Scientific Fellow, Global Biologics U.S. Pharmacopeia Followed by an Industry Perspective presented by Mar... 3 years ago | 84 mins Sanofi’s and SGS’S Implementation of BPOG’S Leachable Risk Assessment model... Ken Wong, Deputy Director at Sanofi Pasteur and Dujuan Lu, Manager/Global Lead of Extractables & Leachables at SGS Full Title: Case Study and Experience on Sanofi's and SGS's Implementation of BPOG's Leachable Risk Assessment Model and Extractable Testing Protocol ... 4 years ago | 89 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... 3 years ago | 88 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
