Thursday 6th February, 2014
9:00am to 6:00pm
Lecture 1: Introduction / Background
Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
Overview of Life Sciences Lifecycle (ICH Q10) and how CSV fits into it
Detecting CSV in predicate rules / guidances
CSV in 21 CFR 11 / Annex 11
The FDA,s 21 CFR 11 Add-On Inspections
Lecture 2: CSV at a High Level
CSV: It's Easy!! Really!!
CSV components and deliverables
CSV & ICH Q9 (Risk Assessment)
Lecture 3: CSV Detailed Study
Exercise on how to create requirements
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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