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Extractables, Leachables, & Elemental Impurities …
PharmaEd Resources, Inc. 2810 Robeson Park Drive Champaign, IL 61822tel. web. , Leachables,& Elemental Impurities 2018 West CoastEnsuring Quality, Safety, and Regulatory Compliance for Drugs & BiologicsNovember 13 14, 2018, Sheraton La Jolla, CAFeaturing Lessons Learned and Case Studies from Industry Experts:And Comprehensive Coverage On:With Representation From:Ping WangSr. Manager J&JKen WongDeputy Director Sanofi PasteurBobbijo RedlerPrincipal Scientist MerckDennis JenkeChief Executive TriadWilliam Beierschmitt Research Fellow PfizerJonathan PetersenSenior Scientist Merck Implementing USP <232> and <233> and ICH Q3D: Updates and Case Studies The Ongoing Development of USP Chapters <665> and <1665> Dealing with Materials and Components Used in Pharmaceutical Manufacturing Systems Injectables Drug Product Long Term Leachable Study Approaches and Regulatory Expectations an Industry-wide Survey Case Study and Experience on Sanofi s implementation of BPOG s Leachable Risk Assessment Model Toxicology Issues in Extractables and Leachables Analytical Challenges in E/L Studies of Pre-Filled Syringes for Oil-Based Drug Formulations Extractables & Leachables Studies on Single-Use Components in Biomanufacturing Advanced Identification Methods for E/L from Packaging & Manufacturing Components Streamlining GC/MS and LC/MS Workflows for Extractables Profiling and Leachables Testing USP <661>, USP < >/< > : A Review of Compendia Bas
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BATCH Q: Quality, Guideline, Elemental Impurities Implementation of ICH Q3D, Elemental Impurities – Implementation of ICH Q3D, Harmonization of Requirements Between ICH Q3D, Lifecycle CMC Management: ICH Q12 Progress, Comments concerning revised texts published in, Comments concerning revised texts published in Supplement