Event Detail
Use GAMP to Surefire your CSV Audit
January 16, 2013 - san francisco CA US
online compliance panel
onlinecompliancepanel1@gmail.com
Phone: 15108575896
Fax: +1-510-509-9659
Regulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation. A third of recent warning letters have cited improper validation and/or incorrect or deficient implementation. After a walkthrough of regulations for CSV, the presentation will transition to a brief explanation of validation enablers as enumerated in ISPE’s GAMP V guide to include the V-model and ASTM’s E-2500 standards. Finally, the webinar addresses e-Validation and their impact on ensuring that Validation is no longer a costly and risky activity. Regulations require validation of medical devices and computer systems used in the production of pharmaceutical and biotechnology products. However, the regulations do not provide a framework for validation. GAMP is a framework devised by industry professionals. It is being used for computer systems validation by companies worldwide. It’s use is considered to be a significant factor in trouble free audits Pricing Live Session for one participant Price: $243.00 Corporate Live Session 4 to 10 participants in single location. Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months. Price: $288.00