Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:
- 21 CFR Part 11 and Computer Validation: Why so many citations?
- Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
- Data Integrity vs Computer Systems Validation
- Overview and Key Requirements of Part 11 & CSV
- How to use a Risk Based Assessment to reduce work while still achieving Compliance?
- How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?
I often refer to 21 CFR 11 and CSV as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement CSV, it is very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up computer validation inspections and the number of citations on the subject are skyrocketing!
This course is appropriate for the beginner and the experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.
This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.
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.What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented
2.How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
3.Data Integrity Frequently Asked Questions
4.Validation Master Plan
5.Risk Based Assessment
6.Complete Validation for a System (software development lifecycle)
Day 1 Schedule
21 CFR 11 & Annex 11
- Introductions / Participants' Understanding
- Participants' Objectives for the Course (Please come prepared to discuss)
- 21 CFR 11 / Annex 11
- 21 CFR 11.10(a) - Computer Systems Validation
- What is Data Integrity
- How does it fit with 21 CFR 11
- FDA's latest guidance
Risk Assessment & Vendor Audits
- Vendor Audits
- Risk Assessment for the System
- Risk Assessment for Requirements
- Gathering Requirements
- Entity Relationship Diagram
- Process Decomposition
- Exercise on how to create Requirements
Day 2 Schedule
- Design Specifications
- Software Configuration and Build
- Exercise on how to create Design Specifications
Verification & Testing
- Traceability Matrix
- Verification and Testing
- Other Documents
- Exercise to create Test Cases
- Equipment Qualification
- Infrastructure Requirements
Change Control & SOPs
- Change Control
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.
- VP of IT
- Director of IT
- Quality Managers
- Project Managers (for DATA INTEGRITY / 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
- Data Managers
- Safety Managers
- Medical Device
- Radiological Health
- Blood Products
- Companion Animals
Venue to be announced shortly.