A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide
This fundamental online 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.
Course Modules/Learning Objectives
- Regulations and Regulators
- GAMP® 5 Overview
- GAMP® 5 Life cycle
- Roles and Responsibilities
- Quality Risk Management (QRM)
- Testing
- Operation Phase
- Effective and Efficient Compliance
Interactive Course includes:
- Engaging graphics.
- Reference materials and links to regulatory information.
- Assessments to measure your comprehension.
- The ability to start and stop at any time, beginning where you left off.
CEUs are provided once you achieve an 80% passing grade and complete the evaluation.
The course is self-paced. On average, the time required for completion ranges from 1 to 3 hours.
Referenced Guide
Attendance suggested for
- 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.