Microlearning: GAMP® Basic Principles – Bundle
Microlearning: GAMP® Basic Principles – Bundle : 15-Part Series
Overview
The GAMP® Microlearning Bundle offers a concise and engaging collection of 15 short learning videos designed to strengthen understanding of key GAMP® 5 principles and their practical application in regulated environments. Each microlearning focuses on a specific topic, ranging from system lifecycle management and data integrity to testing efficiency, supplier management, and risk-based decision-making, providing targeted insights that reinforce foundational knowledge.
This bundle is ideal for professionals seeking flexible, on-demand learning opportunities that fit into a busy schedule while maintaining the depth and rigor expected from GAMP®-aligned training. Learners can explore realistic examples, practical applications, and common industry challenges in short, high-impact segments that promote retention and immediate relevance to daily work.
Together, these modules support a holistic understanding of the GAMP® 5 framework, encouraging a proactive, efficient, and quality-driven approach to computerized system compliance across the product lifecycle.
- Earn CEUs 0.13 (Singles) / 2.0 (Bundle)
- These courses are self-paced. (Courses usually take 15 to 90 minutes to complete.)
- Completing all of the micro-learning GAMP courses in this bundle is equivalent to completing the GAMP Basics Instructor-Led Course.
Courses Include
- Microlearning: GAMP® Basic Principles – Regulations and Regulators
- Microlearning: GAMP® Basic Principles – GAMP® 5 Overview
- Microlearning: GAMP® Basic Principles – GAMP® Life Cycles Detail
- Microlearning: GAMP® Basic Principles – Requirements
- Microlearning: GAMP® Basic Principles – Infrastructure
- Microlearning: GAMP® Basic Principles – Information Management and Tools
- Microlearning: GAMP® Basic Principles – User Supplier Activities
- Microlearning: GAMP® Basic Principles – Computer Software Assurance (CSA)
- Microlearning: GAMP® Basic Principles – Quality Risk Management (QRM)
- Microlearning: GAMP® Basic Principles – Testing of GxP Computerized Systems
- Microlearning: GAMP® Basic Principles – Operational Phase for GxP Regulated Systems
- Microlearning: GAMP® Basic Principles – Effective and Efficient Compliance
- Microlearning: GAMP® Basic Principles – Data Integrity and 21 CFR Part 11
- Microlearning: GAMP® Basic Principles – Validation and Data Integrity for Spreadsheets and End User Applications
- Microlearning: GAMP® Basic Principles – Legacy Systems
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, 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
- Best practices to achieve effective use of AI Course Modules
- Artificial Intelligence & Machine Learning
- Artificial Intelligence & Machine Learning - concepts included in Appendix D11 related to use of AI and ML in GXP-regulated areas
Registration Fee
| Member | Nonmember |
|---|---|
| US$2,005 | US$2,228 |
Buy Now Return to Online Learning
For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses