ISPE Official course: GAMP®: Basic principles (T07)

Date

23-24 July 2025

Venue

Ambassador Hotel, Bangkok, Thailand

Details

GAMP® Basic Principles

This course qualifies for xx.xx CPE credits.


GAMP® Basic Principles 2-Day Training Course

Overview

Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems Second Edition (T07)
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical, biotech, or medical device industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.


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® system lifecycle and specifications
  • 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 and cooperation and leveraging supplier activities and documentation
  • Testing in GAMP® - principles and practical approaches
  • Pragmatic and efficient practices - cost effective compliance


Speaker: 

Mr. David Margetts, ISPE GAMP Certified Trainer 


Registration Fee

  • ISPE Member 8,000 THB
  • Non ISPE Member 12,500 THB


Register to join now!


* Attendance is restricted to a maximum of 40 participants.

** This course qualifies for xx.xx CPE credits.

Return to event index