This course is appropriate for beginner and 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.
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.
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?
Why you should attend
This 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.
Who Will Benefit
- 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
- What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented?
- How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
- Validation Master Plan
- Complete Validation for a System (software development lifecycle)
- Equipment Qualification
- Infrastructure Requirements
Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in Virtual Validation of Software. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Lifesciences industry.
More recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom.