Day 1 – Session

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

Thursday 6th February, 2014

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

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
Validation Plan
Requirements Specifications
Functional Specifications
Exercise on how to create requirements

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 Thu 6th February 2014

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