Use GAMP to Surefire your CSV Audit
Duration: 75 Minutes
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:
Who can Benefit:
- 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
Recorded Session - How it works
- IT Personnel
- Validation Consultants.
- Once you purchase a webinar you will receive username and password at your email address.
- Use the login details to view recorded webinars.
- Presentation handouts will also be shared in pdf format.
- Access to the recording is valid only till 6 months starting from the date of purchase.
- Get certification of attendance.