21 CFR Part 11 - Complete Manual for Compliance and Success
November 13, 2012 - Palo Alto CA US
This 4-hr virtual seminar will provide proven and practical tips on how best to prepare and host an FDA inspection when Part 11 is in scope. It will provide a comprehensive understanding of the elements in Part 11 compliance and show how to practically implement an audit system and audit trails. Why Should You Attend: The trends and reports are showing that FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to support these activities. The number of warning letters is increasing proportionally and most organizations are not ready or prepared to host FDA inspections when Part 11 is in scope. Companies are unsure how to best use and implement audit trails and have challenges with internal and external auditing for Part 11 compliance. This 4-hr session will address all of these topics and provide you with plenty of HOW TOs to increase your comfort level with the regulation, with its elements and compliance, and practically implement audit system and audit trails - especially since audit trails play a major role in Part 11 compliance, they can be your best friends and/or worst enemies at the same time. Event Details: Date: November 13, 2012 Time: 09:00 AM-1:00 PM PDT Cost: $499 per attendee per computer terminal Registration: SIgn-Up on-line now. Add to your shopping cart.