• Medical_Professionals
• Medical_students
• Nurses

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

Angela Bazigos

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. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley's Business School for Executive Education in Life Sciences and on the Stanford Who's Who Registry for contributions to the Lifescience industry.

USD

Group registrations not allowed

Accompanying persons not allowed

We don’t accept Online Abstracts

Submission Info