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.
Note: This course includes the new revised GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems Second Edition.

Participants will focus on the principles and an overview of the overall computer system compliance process, including a scalable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities:
• 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

GAMP, Computerized Systems

REGISTRATION FEE For ISPE/TIPA Member 8,000 THB For Non Member 12,500 THB HOW TO REGISTER 1. Online Registration Browse website https://ispeth.org/event/gamp-t07/, fill-in delegate details and click submit 2. Confirmation ISPE staff will confirm your registration status via email. If not receive email within 2 working days after submitted the form, please contact our staff. 3. Payment Make a payment to reserve your seats and capture/ scan transferred evident i.e. payslip to email REGISTER@ISPETH.ORG REGISTRATION CLOSES ON 21 JULY 2025 OR WHEN ALL SEATS ARE FULLY RESERVED (LIMITED TO 40 SEATS). FIND OUT MORE INFO & CONTACT US: WWW.ISPETH.ORG EMAIL: REGISTER@ISPETH.ORG T: +6688-090-4664