《FDA PDA GAMP Information》.pdf

FDA, PDA, GAMP Information Exchange, May 23, 2001 Up-date on PDA Task Group and GAMP Activities 1 Agenda • Opening (15 min) • Charter and accomplishments (15 min) • Work product updates (20 min) • GERM Conference (20 min) • Affiliations with other groups (20 min) • Q&A (20 min) • Closing and Next Steps (10 min) 2 Opening Remarks and Introductions 3 PDA TG Charter • Primary – Endorse electronic record keeping practices which make sense for FDA regulated companies and which are consistent with 21CFR Part 11 • Secondary – Propose models to facilitate conformance with industry ‘good practices’ and help companies with their compliance activities resulting in a win-win for all stakeholders 4 Deliverables • Describe Current Good Electronic Records Management (GERM) Practices – Surveys (Industry, Agency, Suppliers) – Research (Existing Practices, Legal) – Coordinated Efforts – Glossary of Terms • Legacy System Model • New System Model • Supporting Infrastructure 5 Accomplishments • Survey of Needs – Supplier and Sponsor - completed – Agency – tabled • On-going monitoring of Main Stream events • Established Cooperative Efforts • Conferences • Work products in development Sponsor Survey Highlights •19 surveys returned •Obstacles and