Membership Spring Drive - Join Now!

ISPE GAMP® Basic Principles Training

Basic Principles of Computerized Systems Compliance: Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerized Systems Second Edition (T07)

27 & 28 Aug 2024


This classroom or online course has been updated to include the new revised GAMP® 5 Second Edition.

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.

GAMP 5 Guide 2nd Edition


  • Introduction
  • Regulations and Regulators
  • Requirements of 21 CFR Part 11
  • Overview of GAMP® 5
  • GAMP® 5 Lifecycle in Detail
  • Regulated Company and Supplier Activities
  • Quality Risk Management and Detailed Risk
  • Testing


  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
  • Computer system vendors or consultants, engineering contractors, and validation service companies.


  • Explain the regulatory requirements and expectations for computerized systems used in pharmaceutical manufacturing
  • Apply GAMP® principles to specific systems and cases
  • Describe the GAMP® approach to computerized system compliance
  • Apply these ideas to systems within your own organization


This training course is of particular interest to existing and future members of the ISPE GAMP® Community of Practice (COP)

Uploaded Image

Led by:

David Margetts, CEO, Factorytalk Co., Ltd., Thailand

David Margetts is the CEO of Factorytalk, and an advisor, consultant, and technical expert in the areas of compliance and information technology. David’s background and experience span a wide range of IT solutions for GxP applications, from shop floor systems to the corporate level in the pharmaceutical, biotechnology, and ATMP industries. Before moving to Asia in 2004 to help start Factorytalk, he worked in engineering and validation for Industrial Technology Systems Ltd., in engineering roles for AstraZeneca PLC ,and he is the former Managing Director of Asia for Werum/Koerber Pharma. David is active in ISPE as a certified trainer for computer validation and in Pharma 4.0™ and its Validation 4.0 group. He is both responsible to lead the company and manage critical client assignments for large Pharma MNCs and leading regional manufactures. He has been an ISPE member since 2004.

Limited 1 for 1 Early Bird offer for first 10 registrations! 


Register for the training and get a free conference pass to the ISPE Singapore Conference & Exhibition 2024! Registration fees:

Member US$ 895 / SGD 1,195 Non-ISPE Member US$ 1,095 / SGD 1,485 Government / Academia / Emerging Economies US$ 550 / SGD 735

Secure Your Seat