Process and Product Validation（制程和产品检证）
CSS
学会概要
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:
学会除了针对美食品药品管理局(FDA)发表的制程确效试验手册和品质设计(QbD)方法的解释及引进发表看法外，亦针对知识管理和品质面的危机管理继续检证作业中的作用和影响等，进行讨论作业。
- 考虑制程检证时，因「以3批量检验是否充分」的疑问而造成混乱
- 不确信自家公司的制程是否经常能维持相同品质
- 想知道设计制程、确实实证机能、继续监视维持集成性的方法
- 想知道解释FDA的新辅导手册、编入原有验证计划的方法
在学会中能找到这些问题的解答。
"Great conference with many valuable topics covered." - M. Kane, Associate Director, Process Statistics, HGSI
重点演讲
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
特别演讲
Key Elements of Process Design: Risk Assessments, Design Space and Control Strategy
Amit Banerjee, Ph.D.
Research Fellow, Global Biologics
Pfizer, Inc.
此外，亦深入探讨下列话题
- 制程验证方法的进化和最近的倾向
- QbD、设计空间、FDA新辅导手册的关系
- 有关制程验证之FDA新辅导手册的解释和引进
- 可继续验证的制程之知识管理和生命周期管理
- 制程验证时疑难排解的课题
- 有关制造设施的管理、保护、改善的个案研究和策略