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Process Validation Training Course

工艺验证培训课程

Practical Implementation of Process Validation Lifecycle Approach (T46) - Updated!

践行生命周期模式的工艺验证（T46） -更新版

COURSE DETAILS 课程详情

Course ID课程ID

T46

Level 水平：Intermediate 中等

Communities of Practice 实践范围

Commissioning & Qualification​, Critical Utilities​, Oral Solid Dosage​, Process Analytical Technology​, Process/Product Development​, Sterile​

调试和确认， 关键设施 , 口服固体产品 , 过程分析技术 , 工艺/产品开发 , 无菌制剂等。

Guidance Documents指导文件

ISPE PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example​

ISPE PQLI指南：第2部分-使用QbD的产品实现：实战案例


Overview 概述

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。


What You Will Learn你将学到什么

  • 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。

 

Resources and Activities 资源和活动

Course Modules课程模块

Overview of Stage 1: Process Development

第1阶段概述：工艺开发

  • Regulatory Climate and Surrounding Changes in Process Validation

工艺验证中的监管环境和环境变化

  • Breakout Scenario - Review of Warning Letters

分组讨论-警告信审查

  • Process Validation Basics US and EU

美国和欧盟工艺验证基础

  • Breakout Scenario - Similarities and differences between US and EU

分组讨论-美国和欧盟之间的异同

  • QRM Applied to PV

应用于PV的QRM

  • Breakout Scenario - FMEA

分组讨论-FMEA

  • Developing Understanding of QbD to Develop Robust Control Strategies (PV Stage 1)

加深对QBD的理解，以制定稳健的控制策略（PV阶段1）

  • Breakout Scenario - Case Study

分组讨论-案例研究

  • Wrap-up

总结

Stage 2: Performance Qualification / Process Validation

第2阶段：性能确认/工艺验证

  • Equipment and Qualification

设备和确认

  • Breakout Scenario - Critical Aspects/ Large Molecule

分组讨论-关键方面/大分子

  • Statistics for PV

PV的统计数据

  • Breakout Scenario - Control Charting Basics

分组讨论-控制图表基础知识

  • Readiness for Process Performance Qualification (PPQ) / PV

工艺性能确认（PPQ）/PV的准备

  • Breakout Scenario - Design of PPQ PV Study Protocol

分组讨论-PPQ PV研究方案的设计

  • Acceptance Criteria, Number of Batches, Sampling Plan

验收标准、批数、抽样计划

  • Acceptance Criteria and Sampling Plans for PPQ

产品性能确认的验收标准和抽样计划

  • Breakout Scenario - Acceptance Criteria Sampling Plan

分组讨论-验收标准抽样计划

  • Wrap-up

总结

Stage 3: Continued Process Verification / Ongoing Process Verification

阶段3:持续工艺验证/正在进行的工艺验证

  • Process Validation / PPQ Execution

工艺验证/PPQ执行

  • Breakout Scenario - Analyzing Data

分组讨论-分析数据

  • Continued Process Verification (CPV) / Ongoing Process Verification (OPV)

持续工艺确认（CPV）/持续工艺验证（OPV）

  • Breakout Scenario - CPV and OPV Planning

分组讨论-CPV和OPV计划

  • CPV / OPV for Existing Products

现有产品的CPV/OPV

  • Breakout Scenario - Comprehensive Case Study

分组讨论-全面的案例研究

  • Wrap-up / Review / Quiz Show

总结/回顾/问答节目

 

Who Should Attend谁应该参加

  • This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management.

本课程与制药行业所有部门（小分子和大分子、创新者、仿制药和生命周期管理）中参与产品和工艺的工艺验证的个人相关。

  • Specific job functions including:

具体工作职能包括:

  • Development, manufacturing, engineering, quality, validation compliance, and scientific professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand the concept of process validation as a lifecycle.

开发、制造、工程、质量、验证合规性，以及在开发、制造、工程、验证、质量、技术转让方面具有中级经验的科学专业人员，以及希望了解工艺验证概念的人员。

 

Additional Course Details

其他课程详细信息

This virtual course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for Process Validation to your overall Pharmaceutical Quality System. It will provide you with practical application of quality risk management tools in preparation and planning for validation of your manufacturing control strategy. It will deliver statistical approaches and tools which can be used to strengthen and justify your decision-making rationale for defendable process design and process performance. 

本课程适用于在整个药品生命周期中从事开发、制造、质量以及涉及产品和流程验证的许多其他角色的个人。它将帮助您将基于科学和风险的工艺验证生命周期方法整合并连接到您的整体制药质量体系。它将为您提供质量风险管理工具的实际应用，以准备和规划您的制造控制策略的验证。它将提供统计方法和工具，可用于加强和证明您的可防御流程设计和流程性能的决策依据。

This course will trace the evolution of Process Validation from it's infancy in the 1980's to its current state of maturity. The level of evolution is evidenced with so many relevant guidance documents: ICH Q8, Q9, Q10 and Q11, the upcoming Q12, the 2011 US FDA guideline on Process Validation, EMA's Process Validation documentation (general PV guideline, Annex 15, and biotech products). Now more than ever, there is a need to understand that process validation should be considered a science- and risk-based, life cycle activity rather than a one-time event of manufacture of three commercial scale batches. Companies should demonstrate that processes in the commercial phase of the lifecycle are maintained in a state of control using these techniques.

本课程将追溯工艺验证从20世纪80年代的婴儿期到目前的成熟期的演变过程。许多相关指导文件证明了发展水平：ICH Q8、Q9、Q10和Q11、即将发布的Q12、2011年美国FDA工艺验证指南、EMA工艺验证文件（通用PV指南、附件15和生物技术产品）。现在比以往任何时候都更需要理解工艺验证应被视为基于科学和风险的生命周期活动，而不是三个商业规模批次的一次性生产事件。公司应证明，在生命周期的商业阶段，流程使用这些技术保持在受控状态。

This course will not cover formulation development, the regulatory submission processes or detailed engineering designs and associated qualification.

本课程不包括配方开发、监管提交流程或详细的工程设计和相关资格认证。


Communities of Practice实践社区

This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients, Commissioning and Qualification, Critical Utilities, Oral Solid Dosage, Process Analytical Technology, Product and Process Development, Sterile Communities of Practice (COPs)​.

本培训课程对ISPE的现有和未来成员特别感兴趣，包括活性药物成分、调试和鉴定、关键实用程序、口服固体剂量、工艺分析技术、产品和工艺开发、无菌 实践社区（CoPS） .