Education Sessions
How good are your CSV practices? Benchmarking, Guidance, Case Studies - Two Sessions (705 and 706)
| 705 - 29 October 08.15-11.15 706 - 29 October 12.45-15.45 |
Track: Efficient and Effective Compliance |
ISPE CEUs: 0.2 each session
(PDF Current as of 12 September 2008)
Assess your computer validation or verification system against best practices as described in GAMP® 5. This data will be collated and the feedback will be shared with all delegates allowing them to identify specific areas for improvement. Presentations and workshops will then focus on the areas identified by attendees, which are in most need of improvement. Presentations will deepen understanding, and make practical suggestions for application upon return to work.
How You Will Benefit
At the end of this session, participants will be able to:
- Compare their CSV system with current good practices as reflected in GAMP 5 and with those of other delegates
- Identify improvements that could be made to their CSV systems to reflect good practice
- Apply new ideas which can result in significant cost saving measures
Technical Documents - www.ISPE.org/publications
GAMP® 5: A Risk-based Approach to Compliant GxP Computerized Systems
Who Should Attend
Validation managers and practitioners from industry and suppliers, project managers, IT and controls engineers with responsibility for qualification, validation or verification
ISPE Communities of Practice (COPs)
Commissioning and Qualification (C&Q), Critical Utilities (CU), Good Automated Manufacturing Practice (GAMP), and Process Analytical Technology (PAT)
Session Leaders
- Kathleen Samways, Consultant, KAS Associates, United Kingdom
- David Selby, Managing Director, Selby Hope International Ltd, United Kingdom
Session Speakers
- Paige Kane, Dir Knowledge Mgmt & CoP, Wyeth Pharmaceuticals, USA
- Arthur Perez, Executive Expert, QA, Novartis Pharmaceuticals Corporation, USA