Education Session
603 - Life After GAMP®5: What Comes Next?
11 November 12.45-15.45
ISPE CEUs: 0.25
Tracks: InformationRegulatoryQuality
Sponsored by the ISPE GAMP Community of Practice (COP)
GAMP 5 was published in 2008 to great acclaim around the world. Just having the guide published does not mean the benefits it offers will automatically be achieved. This seminar will look at some of the corporate and culture challenges to effective implementation. The seminar will include workshop elements to explore challenges and how they might be resolved.
How you will Benefit
At the end of this session, participants will be able to:
- Identify some common problems faced by industry in the implementation of GAMP 5
- Explore possible solutions to challenges
Who Should Attend
Computer validation practitioners, quality assurance and quality control management, regulatory compliance and regulatory affairs personnel, information technology and information systems analysts, systems engineers, and maintenance engineers
ISPE Communities of Practice (COPs)
C&Q, GAMP, and PM
View the ISPE Community of Practice (COP) Guide
Session Leaders
- Paige Kane, Dir Knowledge Mgmt & CoP, Pfizer Pharmaceuticals USA
- Guy Wingate, Site Quality Director, GlaxoSmithKline United Kingdom
Session Presenters
- Ellis Daw, Director, GlaxoSmithKline USA
- Carla Wright, Senior Manager Global Engineering, Pfizer USA