Conference on Validation and Part 11 Compliance of Computer Systems and Data

Overview:

Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV.

The Seminar:

This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows:

1. Validation Master Plan
2. Complete Validation for a System
3. Excel Spreadsheet Validation
4. Change Control
5. SOPs
6. Test Tools Validation
7. Project Management for Validation

Who Should Attend?

• VP of IT
• Director of IT
• Quality Managers
• Project Managers (for CSV / IT)
• Validation Specialists
• Database Administrators
• System Administrators
• Directors / Senior Directors of Discovery
• Directors / Senior Directors of Development
• Directors / Senior Directors of Commercialization
• Document Managers
• Training Managers

Speaker:

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Location: Copenhagen, Denmark Date: May 09th & 10th, 2016 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON

Price:

(Without Stay) Price: $1,695.00 (Seminar for One Delegate)

Until April 10, Early Bird Price: $1,695.00 from April 11 to May 07, Regular Price: $1,895.00

(With Stay) Includes Price: $2,095.00 (Seminar for One Delegate)

Until April 10, Early Bird Price: $2,095.00 from April 11 to May 10, Regular Price: $2,295.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com               

Website: http://www.globalcompliancepanel.com

Registration Link - http://bit.ly/validation-and-21-CFR-11-compliance-Denmark