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Good Automated Manufacturing Practice (GAMP) Resources
Articles
Guidance Documents
- GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management (2nd Edition) - Attachments
- GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition)
- GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (Second Edition)
- GAMP® Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP® 5
- GAMP® Good Practice Guide: Electronic Data Archiving
Knowledge Briefs
Online Learning
- 21 CFR Part 11 an Industry Perspective
- A GAMP Interpretation - Annex 11
- Compliance Issues
- Data Integrity and the Human Animal
- Data Warehouse Integrity in Clinical
- Facilities and Equipment: Controls and Automation
- Facilities and Equipment: Design and Construction/Installation
- FDA CDER Announces Part 11 Inspectional Assignments
- FDA: Continuous Manufacturing
- GAMP® 5 Series: Change Management: Computerized Systems including Patch and Upgrade Management
Training Courses
- Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- Complying with Part 11 - Risk Management: Applying the GAMP® Good Practice Guide Electronic Records and Signatures Principles
- Practical Application of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-based Approach to Compliant GxP Computerized Systems
- A Risk-Based Approach to GxP Process Control Systems: Applying the GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems (2nd Edition)
- Practical Approach to Calibration: Applying the GAMP® Good Practice Guide: Calibration Management Principles
- Basic Principles of Computerized Systems Compliance using GAMP® 5, Including Revised Annex 11 and Part 11 Update – New course
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