GAMP® Resources

May / June 2021

May / June 2021

1 May 2021

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

Features

Happy 30th Anniversary to the GAMP® Community of Practice!

1 May 2021

In 2021, the ISPE GAMP^® Community of Practice (CoP) is celebrating 30 years of promoting industry good practice for computerized systems and encouraging technical innovation and progress, while protecting patient...

iSpeak Blog

How Should We Handle Requirements in a GxP Compliant Agile Software Development Process?

1 October 2020

iSpeak Blog

Agile Software Development in GxP Regulated Environments GAMP® Special Interest Group

3 August 2020

iSpeak Blog

Agile Software Development in GxP Regulated Environments Special Interest Group

18 June 2020

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...

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 -...

iSpeak Blog

GAMP® Pragmatic Quality & Risk-Based Approaches: Part 2 Infrastructure - Embrace Automation

4 February 2020

In the previous blog, GAMP® Support for Pragramtic Quality & Risk-Based Approaches, we saw how as part of the Case for Quality program US FDA CDRH (Center for Devices and...

Video

GAMP® Good Practice Guide for GxP Compliant Lab Computerized Systems Webinar

25 June 2019

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...

Video

New GAMP® Data Integrity Good Practice Guidance & Experience from the Field Webinar

30 May 2019

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...