GAMP® 5: Enabling Innovation and Technological Advance - One Day Quick Start - the Best Presentations from the GAMP 5 Launch (E05)
| 3 June 0.6 CEUs |
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Working Agenda Current as of 1 May 2008 Download Working Agenda  PDF, 20 KB |
If you missed the GAMP 5 launch, catch up quickly with this one day seminar that repeats some of the key presentations from the official Guide launches in Tampa and Copenhagen. If you don’t already have a copy of the Guide, attendees will receive a 20 percent discount to purchase the document on site.
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. This seminar will help you learn to apply GAMP 5 principles, and explain how this Guide 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. 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.
Seminar presentations include:
- GAMP 5 – New Material and Enhanced Business Benefit (Wyn)
- Organizational Issues, Including Role of Quality Assurance and Users (Kane)
- Holistic Approach to Science-Based Risk Management in Developing Compliance Solutions (Includes New Categorization) (Perez)
- Hot Topic Appendices (Selby)
- Getting the Most from Leveraging Supplier Work (Cappucci)
- Risk-based Management of Outsources or Offshore Suppliers (Morton)
- Case Study: Melding GAMP 5 with ASTM Processes (Buffi)
- Case Study: Effective and Efficient Compliance (Daw)
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; and
- 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, consultants, or anyone specifying equipment or systems
Communities of Practice (COPs)
Good Automated Manufacturing Practice (GAMP), Commissioning and Qualification (C&Q), and Process Analytical Technology (PAT)
Related Technical Documents Available from ISPE - www.ISPE.org/publications
GAMP® 5
Seminar Leaders
- Paige Kane, Director Knowledge Mgmt & CoP, Wyeth Biotech
- Arthur Perez, PhD, Executive Expert, QA, Novartis Pharmaceuticals Corporation
Speakers
- Winnie Cappucci, PS Compliance IT Sys NA, Bayer Healthcare
- Ellis Daw, Dir Global Computer Validation, GlaxoSmithKline
- Lily Mo, Validation Manager, Pfizer
- 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.