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:
Become aware of document requirements for Computer Systems Validation
Understand how GAMP’s framework fulfills regulatory requirements
Understand the basics of CSV and related regulations
Become familiar with CFR 21 Part 11 validation issues
Review some CSV related 483s and WL
Who can Benefit: