Friday 7th February, 2014
9:00am to 6:00pm
Lecture 4: CSV Detailed Study (Cont'd)
Software Configuration and Build
Verification and Testing
CSV for Excel and other spreadsheets
Lecture 5: CSV implementation in Cloud
Regulatory Compliance for the Cloud
Lecture 6: Business Continuity
Implementing Business Continuity for CSV
Lecture 7: Project Management & QA
Project Management for CSV
How to audit CSV projects
Lecture 8: 483s & Warning Letters
What are 483s & Warning Letters (and other Regulatory Citations)
How to Respond to CSV related citations following an inspection
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 Lifescience industry.
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