ISPE Conference on Manufacturing Excellence
25-28 February 2008
Hyatt Regency Tampa
Tampa, Florida, U.S.
GAMP® 5: Enabling Innovation and Technological Advance (Launch of GAMP 5)
Download Working Agenda (PDF, 29 KB)
This interactive seminar is the official launch of GAMP 5: A Risk-based Approach to Compliant GxP Computerized Systems, and focuses on the principles, concepts, and approaches to computer systems compliance.
GAMP 5 represents a major upgrade to GAMP®4. The previous edition covers aspects of risk management, but GAMP 5 embeds the process and takes it to a new level. GAMP 5 addresses the entire lifecycle of an automated system in detail and is applicable to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures.
This new Guide also examines leveraging supplier capabilities in order to build trust with suppliers and use of their documentation. It recognizes the reality that most businesses no longer build their own software systems, but buy configurable software.
Seminar workshops will help you apply GAMP 5 principles, and explain how GAMP 5 will enhance effectiveness and efficiency back on the job. You will also learn the latest GAMP thinking on interpreting and understanding current regulatory trends. GAMP 5 points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI, ICH Q8, Q9, Q10, and ASTM E2500.
Additional discussion topics based on new Guide information include outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
GAMP 5 has been written by the worldwide GAMP Community of Practice and is the result of collaboration between pharmaceutical companies, suppliers/vendors, consultants and regulators. This is your chance to hear directly from contributors to GAMP 5 and get both a complimentary copy of the Guide and a CD of checklists, templates, diagrams, and other useful resources. GAMP 5 will go on sale shortly after this launch event.
How You Will Benefit
At the conclusion of this session, participants will be able to:
- Apply risk management techniques to minimize effort and maximize compliance
- Structure system development activities to support implementation of compliant systems
- Apply approaches to maintaining a state of compliance throughout the operational lifetime of systems
- Apply approaches to current hot-button issues, such as:
- Qualification of end user applications, such as spreadsheets
- Management of software patch application in a regulatory framework, “review by
exception” for electronic batch records
- The use of open source software in a regulated environment
Who Should Attend
Validation practitioners; quality assurance or compliance specialists; information technology professionals; engineers involved in validation or qualification; anyone involved in implementing or supporting regulated systems; vendors, integrators, and consultants; or anyone specifying equipment or systems.
Communities of Practice (COPs)
GAMP, Commissioning and Qualification, and Process Analytical Technology (PAT)
Related Technical Documents
Available from ISPE - www.ISPE.org/publications
GAMP 5; GAMP Good Practice Guide Series
- Arthur Perez, PhD, Executive Expert, QA, Novartis Pharma Corp
- Peter Robertson, MA, CEng, Senior Manager, Global Quality, AstraZeneca
- Guy Wingate, BSc, MSc, PhD, Quality Director, GlaxoSmithKline
- Jay Buffi, Senior Manager/Team Leader, Pfizer Inc
- Winnie Cappucci, PS Compliance IT Sys NA, Bayer HealthCare
- Paige Kane, Director Knowledge Mgmt & CoP, Wyeth Biotech
- Glenn Morton, Exec Dir, IT Risk Mgmt, Compliance, Novartis Pharmaceuticals Corp
- David Selby, PhD, Managing Director, Selby Hope International Ltd
- Sion Wyn, Director, Conformity Ltd.