Practical Application of Computerised Systems Compliance

Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerised Systems

Wednesday 22 September - Thursday 23 September

Course Content Level: Advanced (includes preliminary online course)

Instructor: Sion Wyn, Conformity Ltd., UK

This highly interactive workshop gives participants hands-on experience in applying practical techniques and solutions to solve computerised systems compliance challenges. Participants will discuss and analyse case studies, apply newly acquired knowledge to hypothetical case-study systems, and have the opportunity to discuss their own real-life challenges with other participants and an expert trainer. Participants should come prepared to work in groups to devise workable and creative solutions to realistic problems and case study scenarios, facilitated by the instructor.

Participants will receive a complimentary copy of the GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Computerised Systems.

Take Back to Your Job:

  • Overview of key themes and concepts in GAMP® 5
  • Understanding the process and overall GxP Risk
  • Effective planning for compliance
  • Supplier assessment and leveraging supplier knowledge and documentation
  • The key role of clear and complete user requirement specifications
  • Choosing a suitable specification and verification approach
  • GAMP 5 Quality Risk Management approach (based on ICH Q9)
  • Specific risk assessment tools for computerised systems
  • Selecting a suitable lifecycle and scaling the lifecycle based on risk, complexity, and novelty
  • Developing a strategy and writing a computerised system validation plan
  • Writing high-quality test scripts
  • Maintaining the control in operation – a scalable approach
  • Regulatory hot topics

Who Should Attend:

  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals, and all levels of management who need a practical understanding of computerised systems compliance
  • Computer systems vendors or consultants, engineering contractors, and validation service companies
  • Those who have previously attended a GAMP Basic Principles training course or those whose practical experience has provided the equivalent level of knowledge
  • This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP)

Online Course Objectives

  • Understand why the industry developed the GAMP guidance, the objectives of the Guidance, the history of the GAMP initiative and how it has evolved
  • Review the structure and content of GAMP 5
  • Define key GAMP 5 themes, concepts, and the GAMP system life cycle

Instructor Biography:

Sion Wyn, Director, Conformity Ltd., is an acknowledged expert in computer system validation and compliance and international regulations in this field. He is currently assisting the FDA with its re-examination of 21 CFR Part 11, and is a member of the team that produced the FDA Guidance on 21 CFR Part 11 Scope and Application. He is the technical content expert for the FDA’s ORA Virtual University online training modules on computerised systems validation and compliance. He has received the FDA Group Recognition Award for work on Part 11. Wyn is the editor of ISPE’s GAMP® 5 Guide - A Risk-based Approach to Compliant GxP Computerised Systems, and is a member of the ISPE GAMP Council, GAMP Editorial Board, and the GAMP Europe Steering Committee. At Conformity Ltd., Wyn provides computer validation and compliance consultancy to the pharmaceutical and other regulated healthcare industries. Wyn received the 2006 ISPE Professional Achievement Award, which honours an ISPE Member who has made a significant contribution to the pharmaceutical manufacturing industry.