Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems (T07)
This classroom course has been updated to include the new revised EU GMP Annex 11, and an overview of 21 CFR Part 11.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical 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 FDA and EU regulatory requirements for GxP computerized systems?
- Revised EU Annex 11 Computerized Systems, including the official GAMP interpretation of key aspects
- FDA 21 CFR Part 11 Overview, including the current FDA interpretation
- How do investigators approach a computer systems inspection?
- Overview of GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- GAMP system lifecycle and specifications
- Quality Risk Management for computerized systems
- Practical Risk Assessment methods
- Scalable specification and verification based on risk
- 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
This course was 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
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide
- Regulations and Regulators
- Requirements of 21 CFR Part 11
- Overview of GAMP® 5
- GAMP® 5 Lifecycle in Detail
- Regulated Company and Supplier Activities
- Quality Risk Management and Detailed Risk
- Operational Phases
- Effective and Efficient Compliance
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, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.
- 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
Community of Practice (COP)
This training course is of particular interest to existing and future members of the ISPE GAMP® Community of Practice (COP).