Process and Product Validation（製程和產品檢證）
CSS
學會概要
Mix-and-match sessions from these additional co-located conferences at no additional cost:
- Technology Transfer for Biopharmaceuticals
- Outsourcing Manufacturing of Biopharmaceuticals
- Biopharmaceutical Raw Materials throughout the Product Lifecycle
- Viral Safety for Biologicals
Stay for the week so you can attend on Feb. 29 - March 2 for these conferences:
學會除了針對美食品藥品管理局(FDA)發表的製程確效試驗手冊和品質設計(QbD)方法的解釋及引進發表看法外，亦針對知識管理和品質面的危機管理繼續檢證作業中的作用和影響等，進行討論作業。
- 考慮製程檢證時，因「以3批量檢驗是否充分」的疑問而造成混亂
- 不確信自家公司的製程是否經常能維持相同品質
- 想知道設計製程、確實實證機能、繼續監視維持整合性的方法
- 想知道解釋FDA的新輔導手冊、編入原有驗證計劃的方法
在學會中能找到這些問題的解答。
"Great conference with many valuable topics covered." - M. Kane, Associate Director, Process Statistics, HGSI
重點演講
Biologics Product & Process Lifecycle Management: Genentech / Roche Experience
David Chang, Ph.D.
Senior Director, Global Biologics Manufacturing Science & Technology
Genentech, Inc., a member of the Roche group
Facility Fit Analysis – The First Step in a Long Journey
Greg Liposky, Ph.D.
Vice President & General Manager, Site Operations
MedImmune
特別演講
Key Elements of Process Design: Risk Assessments, Design Space and Control Strategy
Amit Banerjee, Ph.D.
Research Fellow, Global Biologics
Pfizer, Inc.
此外，亦深入探討下列話題
- 製程驗證方法的進化和最近的傾向
- QbD、設計空間、FDA新輔導手冊的關係
- 有關製程驗證之FDA新輔導手冊的解釋和引進
- 可繼續驗證的製程之知識管理和生命週期管理
- 製程驗證時疑難排解的課題
- 有關製造設施的管理、保護、改善的個案研究和策略