2-day In-person Seminar on Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems at Washington DC

Event Details

Time: September 11, 2014 at 9am to September 12, 2014 at 6pm
Location: Hilton Garden Inn Washington DC Downtown
Street: 815 14th St NW, Washington, DC 20005, United States
City/Town: Washington
Website or Map: http://bit.ly/1ntzVHy
Phone: 18004479407
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: Aug 6, 2014

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Event Description

The Problem:

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:

Validation Master Plan
Complete Validation for a System
Excel Spreadsheet Validation
Change Control
SOPs
Test Tools Validation
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

Industries:

Pharmaceuticals
Biotech
Medical Device
Radiological Health
Blood Products
Companion Animals
Food
Cosmetics
Tobacco
Academia

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