Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems Second Edition (T45)
Overview
This classroom or online course has been updated to include the new revised GAMP® Second Edition.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
What You Will Learn
- What are the international regulatory requirements for GxP computerized systems, including US 21 CFR Parts 211 and 11, and EU Annex 11?
- Overview of GAMP® 5 Second Edition Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- GAMP® 5 system lifecycle
- Scalable specification and verification based on risk
- Quality Risk Management for computerized systems
- Practical Risk Assessment methods
- Updated GAMP® Categories
- Role of users and suppliers - assessment and cooperation and leveraging supplier activities and documentation
- Testing in GAMP® - principles and practical approaches
- Pragmatic and efficient practices - cost effective compliance
- The role of IT Infrastructure in ensuring a compliant computing environment
- Effective and efficient approaches to end-user applications, including spreadsheets
This course is developed by members of the ISPE GAMP® Community of Practice. GAMP® was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.
Resources and Activities
- Extensive Interactive Exercises
- GAMP® 5 Second Edition: A Risk-Based Approach to Compliant GxP Computerized Systems Guide
Course Modules
- Introduction
- Regulations and Regulators
- Data integrity requirements, including 21 CFR Part 11
- Overview of GAMP® 5 Second Edition
- GAMP® 5 Lifecycle in Detail
- Developing User Requirements
- Regulated Company and Supplier Activities
- Quality Risk Management
- Testing
- Operational Phases
- Effective and Efficient Compliance
- IT Infrastructure
- End-user applications, including spreadsheets
Who Should Attend
- 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
- Computer system vendors or consultants, engineering contractors, and validation service companies
Additional Course Details
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering. It provides the principles and an overview of the overall computer systems compliance process, including a scalable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP® categories, supplier assessment, and the selection of appropriate specification and verification activities.
Learning Objectives
- Explain the regulatory requirements and expectations for computerized systems used in pharmaceutical manufacturing
- Apply GAMP® principles to specific systems and cases
- Describe the GAMP approach to computerized system compliance
- Apply these ideas to systems within your own organization
Communities of Practice
This training course is of particular interest to existing and future members of the GAMP® Community of Practice (COP).