Day 2 – Session

A session at 2-day In-person Seminar on “Computer System Validation - Reduce Costs and Avoid 483s” at Chicago IL

Friday 7th February, 2014

9:00am to 6:00pm (CST)

Lecture 4: CSV Detailed Study (Cont'd)
Design Specifications
Software Configuration and Build
Traceability Matrix
Verification and Testing
Validation Report
Validation Registry
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

About the speaker

This person is speaking at this event.
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 Lifescience industry.

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Time 9:00am6:00pm CST

Date Fri 7th February 2014

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