Process Validation 工艺验证 主题活动

Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry.  How many lots should I make?  Are we taking enough samples?  Do we need to use statistics in our protocols?  The real question may be: am I even focusing on the right questions?

生命周期工艺验证（PV）仍然是制药行业中最重要和最常被误解的话题之一。我应该做多少批？我们采集的样本够吗？我们需要在方案中使用统计数据吗？真正的问题可能是：我甚至是否聚焦于了提出正确的问题？

Course participants will focus on the practical application of the lifecycle approach to all stages of PV to gain valuable knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry.

课程参与者将重点关注生命周期方法在工艺验证所有阶段的实际应用，以获得关于行业当前使用的法规、指南和最佳实践的宝贵知识和见解。

• Course participants will focus on the practical application of the lifecycle approach to all stages of PV to:

课程参与者将重点关注生命周期方法在PV所有阶段的实际应用，以:

• Understand the importance of product and process understanding and patient requirements.

了解产品和工艺流程认知的重要性以及患者的要求。

• Know how to apply QRM tools for PV.

了解如何将QRM工具应用于PV。

• Recognize opportunities to leverage process design information to establish a process validation strategy and a process performance and product quality monitoring program.

识别利用工艺设计中获得的认知来建立工艺验证策略和工艺性能及产品质量监控计划的机会。

• Understand the challenges to the application of an entirely science- and risk-based approach.

了解完全基于科学和风险管理的方法进行验证时将面临的挑战。

• Understand a variety of approaches to applying specific expectations of the lifecycle approach to PV including number of sampling, acceptance criteria and determining the number of batches for PPQ/PV.

了解将生命周期方法的特定期望应用于PV的各种方法，包括抽样数量、可接受标准和确定 PPQ /PV的批次数量。

• Understand the differences in expectations among various major world markets.

了解全球各主要市场之间的预期差异。

• Learn various approaches for deciding which attributes and parameters should be evaluated at a heightened level during PV stage 3.

学习不同的方法，以决定在PV阶段3期间应在更高级别评估哪些属性和参数。

• Understand new expectations for routine process monitoring.

了解对日常工艺过程监控的新期望。

• Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system.

了解工艺验证周期和维持有效的制药质量体系的重要性。

• Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement.

运用工艺表现和产品质量监控体系要素，识别持续改进的机会。

• Minimize chance of validation failures by learning about adequate preparation in process understanding and ancillary systems.

通过学习关于使用足够充分的工艺知识认知以及其附属系统，来最大限度地减少验证失败的机会。

• Acquire tools to prepare for a smooth validation execution.

获取工具，为顺利执行验证做准备。

• Understand implications of validation deviations.

理解验证偏差的含义。

• Maximize and be able to apply your understanding of ICH terminology including the principles of a science- and risk-based approach to the process validation lifecycle.

最大限度地将您对ICH术语的理解（包括基于科学和风险的方法的原则）应用于工艺验证生命周期。

• Recognize the value of the requirements of management’s responsibilities within the PQS.

认识PQS中对于管理层职责要求的价值。