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Today is Sep 5, 2010
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David Nettleton is a 21 CFR Part 11, HIPAA, 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. He has completed more than 135 computer system validation projects for mission critical applications.
David will present an introduction to the new Health Insurance Portability and
Accountability Act (HIPAA) Security regulations that becomes effective
in 2005. This session discusses the evolution of 21 CFR Part 11 and
the specifics of the regulation as it relates to electronic records
and electronic signatures.
Being one of the nations foremost experts on CSV for 21CFR Part 11, David has co-authored two books on the subject with Janet Gough: "Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance", and "Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164" .
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