Mr. David Nettleton

Area Of Expertise : FDA Compliance Specialist
27 Years Of Experience
Training Industry : Life Sciences

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, 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. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project. He has completed more than 225 mission critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

2 results Found
Live Webinar

Data Integrity and Privacy: compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

Details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation This highly interactive training uses life examples and explores proven techniques for reducing costs, usual ...

  • Basic & Intermediate
  • 90 Mins
  • Oct 08, 2019
Live Webinar

The 6 Most Common Problems in FDA Software Validation and Verification

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

  • Basic & Intermediate & Advanced
  • 120 Mins
  • Nov 18, 2019