Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced-2014-09-10

Event details: 
Title: 

Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

Event dates: 
Thursday, September 11, 2014 to Friday, September 12, 2014
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.

This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools.

The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system.

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

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

Event type: 
Course
Language: 
English
Event location: 
Hilton Garden Inn Washington DC Downtown
815 14th St NW
Washington, DC 20003
United States
Event position: 
Organizer details: 
Contact name: 
John Robinson
Organization: 
GlobalCompliancePanel
Location: 
161 Mission Falls Lane
Suite 216
Fremont, CA 94539
United States
Event information: 
Chemistry techniques: 
Registration deadline: 
Tuesday, September 9, 2014
Abstracts deadline: 
Tuesday, September 9, 2014
Posters deadline: 
Monday, September 8, 2014
Keynote speakers: 

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.

Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life sciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality

Session titles: 

Day 1 – Agenda
Lecture 1: Introduction / Background
• Introductions / Participants' Understanding
• Participants' Objectives for the Course (Please come prepared to discuss)
Lecture 2: Requirements at a High Level
• Types of Requirements
• Difference between User Requirements & Functional Requirements
Lecture 3: Detailed Requirements Study
• Gathering Requirements
• Entity Relationship Diagram
• Process Decomposition
• Risk Assessment for Requirements
• Exercise on how to create Requirements
Lecture 4: Design
• Design Specifications
• Software Configuration and Build
• Exercise on how to create Design Specifications

Day 2 – Agenda
Lecture 5: CSV Detailed Study (Cont'd)
• Traceability Matrix
• Verification and Testing
• Exercise Creating Validation Scripts
• Exercise Creating Traceability Matrix
Lecture 6: Other Documents
• Validation Plan
• Test Protocols
• Validation Report
• Validation Registry
Lecture 7: Special Topics
• Project Management for CSV
• Infrastructure for CSV
• Selecting software for 21 CFR 11 Compliance
• Test Tools for CSV
Lecture 8: Change Control & Business Continuity
• Change Control
• Implementing Business Continuity for CSV

Registration fees and grants: 

Price: $1295.00 (Seminar for one Delegate)
Discount:
Register now and save $200. (Early Bird)
Until July 31, Early Bird Price: $1,295.00
From August 01 to September 09, Regular Price: $1,495.00