GAMP® Resources

Online Live
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
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 -...
Video
This webinar provides an overview of new and forthcoming ISPE GAMP® Data Integrity guidance and real-world experiences on applying data integrity in the field. The speakers will address the following topics: Overview of...
Video
This webinar will discuss the lifecycle of computerized laboratory equipment, with some discussion of the similarities and differences to computer system validation, and the use of quality risk management to right-size...
iSpeak Blog
Background As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...
Features
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...