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 Webinars
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
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