- Exercise Creating Traceability Matrix
Lecture 6:
Other Documents
- Validation Plan
- Test Protocols
- 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
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. 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 Life science industry.
