GAMP® Resources

Training
Training

GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course

The importance and amount of data being generated to ensure product quality and patient safety continues to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result....
New GAMP SIG Explores Computer Software Assurance
iSpeak Blog
New GAMP SIG Explores Computer Software Assurance

ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV, enabling industry to focus validation efforts on critical systems and functionality.

Pharmaceutical Engineering
PE Magazine

May / June 2021

IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure...
Online Live Training
Online Live

GAMP® 5, Annex 11/Part 11 Basic Principles Online Live Training

Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...
Online Live Training
Online Live

Data Integrity & Compliance for GxP Process Control Systems Online Live Training

Online Live Overview This highly interactive virtual course describes how the GAMP® Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems, and GAMP® RDI Good Practice Guide: Data Integrity -...