Use GAMP to Surefire your CSV Audit Description: 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. Why Should you Attend: This webinar demonstrates the use of GAMP to determine what needs to be validated, the amount of validation that is required and how to establish a documentation strategy for recording the validation outcomes. It also covers proven techniques for creating documents that meet regulatory requirements. Objectives of the Presentation: At the end of the webinar, participants will: o Become aware of document requirements for Computer Systems Validation o
Understand how GAMP’s framework fulfills regulatory requirements
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Understand the basics of CSV and related regulations Become familiar with CFR 21 Part 11 validation issues
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Review some CSV related 483s and WL
Who can Benefit: o QA o
QC
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Engineering IT Personnel
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Manufacturing
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Validation Consultants.
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Wednesday, January 16, 2013 10:00 AM PST | 01:00 PM EST
Live Session for one participant
Price: $243.00 Corporate Live Session 3 to 4 participants in single location. (For muliple location contact customer care)
Price:$486.00 Corporate Live Session 5 to 10 participants in single location. (For muliple location contact customer care)
Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $288.00