21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s

Start Date : 2012-01-31
End Date : 2012-01-31
Time : 10:00 am - 11:30 am

Phone : +1-650-620-3915

Location : United States of America
2600 E. Bayshore Road, Palo Alto, CA

Industry : Education,Academy;

No maps provided.

Description

This 21 CFR Part 11 compliance training will guide you through the concept of part 11 and explanation of its 3 primary areas SOPs, Product features and Validation (10 step risk based approach).

Why Should You Attend:
This webinar describes exactly what is required to be 21 CFR Part 11 compliant. It takes the concepts of Part 11 and expands them into specific things to do in all three primary areas: SOPs, product features, and validation. All required IT SOPs are described. Product features based on the current industry standards are explained in detail. The 10-step risk-based validation approach is outlined so that the specific documents for a validation project are understood.

This is the first webinar in a series and it takes the mystery out of what is needed for 21 CFR Part 11 compliance. It will help you to eliminate 483s and Warning Letters.