Overview

概述

As cleaning technology and detection methodology advance, so do the challenges associated with establishing, managing, and maintaining a scientifically sound cleaning validation program. With the FDA's risk-based regulatory initiatives focusing new attention on the risks of cross-contamination understanding lifecycle management techniques for an effective cleaning validation program is paramount. This training course covers the risk-based approach to cleaning development and verification; risk analysis; procedures and evaluation tools including FMEA / FMECA, master planning, risk control, PAT, periodic assessment and monitoring, risk review and communication.

随着清洁技术和检测方法的进步，与建立、管理和维护科学合理的清洁验证程序相关的挑战也在增加。随着FDA基于风险的监管计划将新的注意力集中在交叉污染的风险上，了解有效清洁验证计划的生命周期管理技术至关重要。该培训课程涵盖了基于风险的清洁开发和确证方法；风险分析；程序和评估工具，包括FMEA/FMECA、主计划、风险控制、PAT、定期回顾和监控、风险评审和沟通。

What You Will Learn

你将学到什么

• Elements of a cleaning validation program from start to finish

从始至终的清洁验证程序的要素

• Exploring such concepts as the determination of residues to be targeted

探索确定目标残留物等概念

• Selection of analytical and sampling methods

分析和取样方法的选择

• Determination of appropriate limits in various pharmaceutical and biotechnology processes

各种制药和生物技术过程中适当限度的确定

• Establishment of scientific rationales acceptable to regulatory inspectors

建立监管检查员可接受的科学原理

• For mature cleaning validation programs, concepts such as understanding process control, capability

对于成熟的清洁验证计划，了解过程控制、能力等概念

• Learning to effectively self-audit a cleaning validation program and documentation

学习有效地自我审核清洁验证计划和文件

Resources and Activities

资源和活动

• Pre-Course Work Materials

课前作业材料

• Interactive Exercises

互动练习

• Learning Assessments

学习评估

• Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls​

指南：清洁验证生命周期-应用、方法和控制

Course Modules

课程模块

• Regulatory Requirements for Cleaning Validation

清洁验证的法规要求

• Goals of Cleaning: Risk and Science

清洁的目标：风险与科学

• Risk Assessment: Risk Identification

风险评估：风险识别

• Risk Assessment: Risk Analysis

风险评估：风险分析

• Risk Assessment: Risk Evaluation

风险评估：风险评估

• Risk Control: Risk Reduction

风险控制：风险降低

• Method Validation and Recovery Studies

方法验证和回收率研究

• Documentation for Cleaning Validation

清洁验证文件

• Risk Review and Risk Communication

风险回顾和风险沟通

Who Should Attend

谁应该参加

• Professionals responsible for all aspects of cleaning validation programs, including development, deployment, and maintenance

负责清洁验证计划的所有方面的专业人员，包括开发、使用和维护

• Quality assurance specialists, quality control technicians, regulatory affairs professionals, pharmacologists and toxicologists, validation scientists, and validation service personnel

质量保证专家、质量控制技术人员、法规事务专业人员、药理学家和毒理学家、验证科学家和验证服务人员

• Manufacturing supervisors, technical support personnel, and engineers responsible for evaluating cleaning systems, reviewing equipment, and supporting the cleaning validation program on the plant floor

负责评估清洁系统、审查设备并支持工厂的清洁验证计划的生产主管、技术支持人员和工程师

• All levels of management who need to understand the science of cleaning and cleaning validation including the aspects of residue selection, sampling method and analytical detection method validation, limits determination, and strategies for managing multi-product facilities

需要了解清洁和清洁验证科学的各级管理人员，包括残留物选择、取样方法和分析方法验证、限值确定以及管理多产品生产设施的策略

Additional Course Content

附加课程内容

• Risk-Based Approach to Cleaning Development and Verification

基于风险的清洁开发和验证方法

• Risk and Hazard Identification

风险和危害识别

• Science-Based and Risk-Based Limits

基于科学和基于风险的限度

• Risk Analysis

风险分析

• Cleaning Process Risk Analysis and Process Development

清洁工艺风险分析和工艺开发

• Cleaning Equipment Design and Qualification

清洗设备设计和确认

• Cleaning Control Strategy

清洗控制策略

• Sampling

取样

• Analytical Methods for Assessment of Cleaning

用于评估清洁的分析方法

• Risk Analysis of Cleaning Procedures

清洁程序的风险分析

• Risk Evaluation

风险评估

• Tools for Risk Analysis in Cleaning

清洁中的风险分析工具

• FMEA / FMECA

FMEA/FMECA

• Risk-based Analysis of Cleaning Data

基于风险的清洗数据分析

• Risk Analysis Master Planning

风险分析总体规划

• Assessment and Monitoring

评估和监测

• Risk Control

风险控制

• PAT approaches to Cleaning Validation

清洁验证的PAT方法

• Periodic Assessment and Monitoring

定期评估和监测

• Risk review

风险回顾

• Risk Communication

风险沟通

Learning Objectives:

学习目标:

• Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents

识别和描述潜在残留物，包括产品、辅剂、清洁剂和外源性物质

• Apply appropriate analytical methodology for selected residues

对选定的残留物采用适当的分析方法

• Determine suitable sampling techniques and the selection of sampling locations that present a challenge for the cleaning process

确定合适的取样技术，并选择对清洁过程构成挑战的取样位置。

• Calculate residue limits that meet all necessary regulatory requirements

计算满足所有必要监管要求的残留限量

• Create scientifically sound rationales, validation protocols, and reports

创建科学合理的基本原理、验证方案和报告

• Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state

管理多产品生产设施在建立限度、确定验证策略和维持验证状态方面的挑战

• Understand campaign-based production strategies for effective and scientifically sound validation

了解基于活动的生产策略，以进行有效且科学合理的验证

• Differentiate the requirements for cleaning validation when using manual, semi-automatic, and automatic cleaning technologies

在使用手动、半自动和自动清洗技术时，区分清洁验证的要求

• Determine scientific grouping or bracketing approaches

确定科学的分组或分类方法

• Comprehend the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products

了解生物制药和医药产品生产后清洗的固有缺陷

• Accomplish analytical method validation and recovery study requirements in cost-effective studies that provide the necessary assurance of an analytical system

在为分析系统提供必要保证的成本效益研究中，完成分析方法验证和回收率研究要求

• Evaluate cleaning practices, limit calculations, scientific rationales, and validation documents through internal self-audits to ensure compliance with ever-changing regulatory needs

通过内部自我审核评估清洁实践、限度计算、科学原理和验证文档，以确保符合不断变化的法规需求

• Practice hands-on exercises designed to reinforce core competencies and job-focused skills

实践动手练习，旨在加强核心能力和以工作为中心的技能