Education Sessions

E-IN5a, b, & c
Introduction to GAMP® 5: Science and Risk-Based Tools for Right-Sizing Computer Validation
(Three Successive Sessions)

6 November 14.15-17.30
7 November 09.00-12.00
7 November 13.00-16.00		 Track: Innovation

ISPE CEUs: 0.7

Good Automated Manufacturing Practice (GAMP) has always been at the forefront of Delivering Today, Transforming Tomorrow. The next version of the GAMP Guide for Validation of Automated Systems (GAMP5) introduces important tools to ensure that ISPE’s computer validation guidance reflects current industry and regulatory thinking regarding the incorporation of science-based risk management principles into the efforts of validating computer applications and qualifying regulated equipment.

This emphasis on well-understood processes and potential risk to patient safety aligns with initiatives such as FDA’s cGMPs for the 21st Century and ICH Q8, Q9, and Q10. Within this scope, leveraging the work of suppliers is also a key factor.

Highly-anticipated, GAMP5’s first introduction is this session. Come and learn about the science-based risk management approach to computerized systems, revised and refined key concepts, and new guidance specifically aimed at effective and efficient compliance and fitness for intended use.

Take Back to Your Job

  • Apply the right effort for validation with science and application of risk management
  • Know tools for risk management for computer systems compliance
  • Understand how the new GAMP Guidance fits into the overall scope of emerging industry consensus standards such as ASTM and ISO, and other ISPE guidances such as the forthcoming Commissioning and Qualification Baseline® Guide

Who Should Attend

Individuals involved with the validation or qualification of computerized systems in the pharmaceutical, biotech, medical device, or healthcare industry. This includes professionals from QA, IT, Engineering, the laboratory, and validation groups.

Community of Practice: Good Automated Manufacturing Practice (GAMP)

Agenda for E-IN5a: What’s New in GAMP5?

  • Evolution from GAMP1 to GAMP5, concentrating on new material and evolved principles in GAMP5 (including business benefits)
  • Organizational issues, including the role of QA and users
  • Getting the most from leveraging supplier work

Agenda for E-IN5b: Applying Science-Based Risk Management to Computer Validation

  • Holistic approach to science-based risk management in developing high-quality applications (includes new categorization)
  • New approach to appropriately scaled operational controls
  • Workshop: Applying GAMP5 principles to scaling validation and operational controls

Agenda for E-IN5c: How Does GAMP5 Fit into the Overall Picture?

  • Alignment with evolving industry standards
  • Alignment with C&Q
  • Ensuring efficient validation within the scope of industry best practice
    Innovation

Session Leaders

  • Arthur Perez, Executive Expert, QA, Novartis Pharmaceuticals Corporation
  • David Selby, Managing Director, Selby Hope International Ltd
  • Sion Wyn, Director, Conformity Ltd.

Session Speakers

  • Winnie Cappucci, PS Compliance IT Sys NA, Bayer Healthcare
  • Anthony Margetts, Director, Margetts Associates
  • David Petko, Senior Director, Auxilium Pharmaceuticals, Inc.
  • Sabra Seyer, Global PNS Director, Pfizer

 

Sponsors