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David Nettleton

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David Nettleton

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.

Live Webinar

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By: David Nettleton

Nov. 7, 2024

2-Hour Virtual Seminar on the 6 Most Common Problems in FDA Software Validation and Verification

This Seminar describes the validation planning process with particular emphasis on avoiding six common pitfalls. Increased use of software from automated manufacturing and quality systems means in…

Industry: FDA Compliance   Duration: 120 Minutes   Time: 12:00 PM PDT | 03:00 PM EDT

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By: David Nettleton

Nov. 20, 2024

Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applica…

Industry: FDA Compliance   Duration: 90 Minutes   Time: 10:00 AM PDT | 01:00 PM EDT

Recorded Session