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Today is Sep 5, 2010
May 12, 2003
Time: 11:30 AM to 1:00 PM
Topic: Latest 21 CFR Part 11 Guidelines and The 5 W's of Computer System Validation (Who, What, Where, When, Why...and Their Common Errors)
Speaker: David Nettleton
Speaker's Website: http://www.computersystemvalidation.com
Location: Connetics
3290 West Bayshore Road
Palo Alto, California
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Speaker Biography
David Nettleton is a 21 CFR Part 11 Specialist and Computer System Validation consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. Services include gap analysis, remediation plans, SOP development, vendor audits, training, and project management. David has completed more than 120 computer system validation projects for mission critical applications involving; blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets developed for regulated applications, Internet billing, laboratory instruments, laboratory information management, manufacturing, enterprise resource planning, medical device software, MRI software, nuclear power plant maintenance, pharmaceutical, retail software including Visio and MS Windows operating systems, server room moves, toxicology systems, and environmental monitoring.
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