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2day Inperson Seminar on Advanced Course Validation and 21 CFR 11 Compliance of Computer Systems

7/24/2014 9:00 AM - 7/25/2014 6:00 PM

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

Course Description:

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

o Test Reports

• 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

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


• Pharmaceuticals

• Biotech

• Medical Device

• Radiological Health

• Blood Products

• Companion Animals

• Food

• Cosmetics

• Tobacco

• Academia

About 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.

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 Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.


Location: SFO, CA Date: July 24th & 25th, 2014 Time: 9 AM to 6 PM EDT


Price: $1,295.00


Register now and save $200. (Early Bird)

Until July 15, Early Bird Price: $1,295.00

From July 16 to September 09, Regular Price: $1,495.00

Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884



EVENT Link –


NetZealous LLC,

DBA GlobalCompliancePanel,

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

Phone: 1800 447 9407

Learn More: 2day Inperson Seminar on Advanced Course Validation and 21 CFR 11 Compliance of Computer Systems

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