GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

GAMP®数据完整性21 CFR Part 11，为期2天的培训课程

A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems (T70)

关于数据完整性、电子记录和签名以及GxP计算机化系统（T70）运行的GAMP®方法

Overview

概述

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.

为确保产品质量和患者安全而生成的数据的重要性和数量不断增加，围绕这些数据的适当控制仍然是监管审查的主题。世界各地的监管机构都在反复提到数据完整性问题。因此，行业指南和执法战略正在演变。监管问题和警告信已扩展到制药、生物技术和医疗设备业务的所有领域，包括制造、开发、临床、药物警戒和产品生命周期的其他领域。本课程将涵盖数据完整性、电子记录和签名以及GxP计算机化系统的合规运行，用以提供工具和技术来实施适当的数据控制，从而确保信息在整个数据生命周期中的完整性和有效性。

What You Will Learn

你将学到什么

This training course will provide a practical understanding of the following:

本培训课程将提供对以下内容的实践性理解:

• The current regulatory focus on Data Integrity, including a detailed discussion of US 21 CFR 11

当前对数据完整性的监管重点，包括对US 21 CFR Part 11的详细讨论

• Relevant regulatory observations

相关监管意见

• Current regulatory Guidance on Data Integrity

当前数据完整性的监管指南

• The need for Data integrity throughout the system and data life cycles

在整个系统和数据生命周期中需要保持数据完整性

• Detailed examination of the data life cycle

数据生命周期的详细检查

• The requirement for a data governance framework

数据治理框架的要求

• A data integrity maturity model

数据完整性成熟度模型

• How to meet the international regulatory requirements for electronic records and signatures

如何满足电子记录和签名的国际监管要求

• Overview of the requirements of 21 CFR Part 11 electronic records and signatures, concentrating on the FDA Scope and Application Guidance

概述21 CFR第11部分电子记录和签名的要求，重点关注于FDA范围和指南应用

• How to meet the requirements of other relevant regulations including EU Annex 11

如何满足包括欧盟附件11在内的其他相关法规的要求

• How to apply the current industry risk-based good practice approach to compliant electronic records and signatures

如何将当前行业基于风险的良好实践方法应用于合规电子记录和签名

• How to maintain Data Integrity through the GAMP® system life cycle and beyond

如何在GAMP®系统生命周期及以后保持数据完整性

• How cloud computing approaches can impact data integrity

云计算方法如何影响数据完整性

• Data integrity and mobile apps

数据完整性和移动应用程序

• Data mapping as an important tool in ensuring data integrity

数据映射是确保数据完整性的重要工具

• How to apply the new ISPE GAMP® Guide: Records and Data Integrity including:

如何应用新的ISPE GAMP®指南：记录和数据完整性，包括:

• Data Governance Framework

数据治理框架

• Culture and Human Factors

文化与人文因素

• Data Life Cycle

数据生命周期

• Applying Quality Risk Management to Data Integrity

将质量风险管理应用于数据完整性

Resources and Activities

资源和活动

• Extensive Interactive Exercises

广泛的互动练习

• ISPE GAMP® Guide: Records and Data Integrity​

ISPE GAMP®指南：记录和数据完整性

Course Modules

课程模块

• Introduction

介绍

• Data Integrity through the Lifecycle

数据在整个生命周期中的完整性

• MHRA Data Integrity Guidance

MHRA数据完整性指南

• Regulatory Citations for Data Integrity

数据完整性的法规引用

• Data Governance

数据治理

• EU Annex 11 and Chapter 4

欧盟附录11和第4章

• Compliant Operation of GxP Regulated Systems

GXP监管系统的合规运行

• 21 CFR Part 11 Electronic Records and Signatures

21 CFR Part 11电子记录和签名

• Data Integrity for Spreadsheets

电子表格的数据完整性

• Mobile Devices and Cloud Computing

移动设备和云计算

• ISPE GAMP® Guide on Record and Data Integrity

ISPE GAMP®记录和数据完整性指南

Who Should Attend

谁应该参加

• All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.

所有在GXP监管环境中工作的人员，其需要具备数据完整性、电子记录和签名以及GxP计算机化系统的相关运行方面的工作知识。

• Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation and risk management approaches to achieving electronic record and signature compliance.

需要对21 CFR Part 11法规和风险管理方法有基本了解以实现电子记录和签名合规性的任何人。

• Computer system vendors or consultants, engineering contractors, and validation service companies.

计算机系统供应商或顾问、工程承包商和验证服务公司。

• Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.

质量保证和质量控制专家、验证专家、生产主管、技术支持人员、工程师、MIS专业人员以及需要对计算机化系统合规性和法规有基本了解的各级管理人员。

Additional Course Details

其他课程详细信息

It is recommended that course participants have a basic awareness of GxP regulations and/or the use of computerized systems in a regulated environment. Some knowledge of the GAMP® approach to computerized systems compliance would be an advantage.

建议课程参与者对GxP法规和/或在受监管环境中使用计算机化系统有基本的了解。了解GAMP®的计算机化系统合规方法将是一个优势。

Learning Objectives:

学习目标:

• Understand the current regulatory focus on Data Integrity and the relevant regulatory observations

了解当前对数据完整性的监管重点以及相关监管意见

• Review the new MHRA Guidance on Data Integrity

查看新的MHRA数据完整性指南

• Analyze the need for Data Integrity throughout the life cycle

分析整个生命周期中对数据完整性的需求

• Evaluate the requirements for a robust data governance system

评估稳健数据治理系统的需求

• Know how to meet the requirements of 21 CFR Part 11 electronic records and signatures, including the USFDA interpretation in the Scope and Application Guidance, and international regulatory requirements for electronic records and signatures including Annex 11

了解如何满足21 CFR Part 11电子记录和签名的要求，包括USFDA在范围和应用指南中的解释，以及电子记录和签名的国际监管要求，包括附录11

• Apply the current industry risk-based good practice approach to compliant electronic records and signatures

将当前行业基于风险的良好实践方法应用于合规电子记录和签名

• Understand approaches to cloud computing and mobile applications in the GxP environment

了解在GXP环境中的云计算和移动应用程序的方法

• Understand the Key Concepts and approaches of the ISPE GAMP® Guide on Record and Data Integrity

了解ISPE GAMP®记录和数据完整性指南的关键概念和方法



Community of Practice (COP)

实践社区（COP）

This training course is of particular interest to existing and future members of the GAMP®​ Communities of Practice (COP).

该培训课程特别适合GAMP®​实践社区（COP）的现有和未来成员。。