Speaker Profile


David Nettleton

FDA Compliance Specialist

Leader, Author and Teacher for 21 CFR Part 11

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. He has completed more than 270 mission critical laboratory, clinical, and manufacturing software implementation projects. 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.

Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory inspections: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.

Projects involve: medical devices, blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets, laboratory instruments, laboratory information management (LIMS), manufacturing, enterprise resource planning, toxicology systems, and VMWare.

David Nettleton is also the co-author of:

  • Managing the Documentation Maze – Answers to Questions You Didn’t Even Know to Ask Wiley 2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA 2003).



2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR
2 Days - Data Integrity: compliance with 21 CFR Part 11, Annex 11, SaaS/Cloud, and EU GDPR

Speaker:David Nettleton
Time: 5th March 2019 05:00 AM PDT | 08:00 AM EDT
Duration:1000 Minutes
Model : GRCSEM-6235

Tue
05
Mar 2019

21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR
21 CFR Part 11 Data Integrity: How to Validate Software for SaaS/Cloud, EU, GDPR

Speaker:David Nettleton
Time: 28th January 2019 10:00 AM PDT | 01:00 PM EDT
Duration:70 Minutes
Model : GRC-90467

Mon
28
Jan 2019

Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance
Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

Speaker:David Nettleton
Time: 12th December 2018 10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Model : GRC-90285

Wed
12
Dec 2018

Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance
Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

Speaker:David Nettleton
Time: 12th December 2018 10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Model : GRC-90485

Wed
12
Dec 2018

One Day Workshop -  Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance
One Day Workshop - Excel Spreadsheet Validation-Step by Step Guide to Data Integrity Compliance

Speaker:David Nettleton
Time: 7th March 2019 05:00 AM PDT | 08:00 AM EDT
Duration:1000 Minutes
Model : GRCSEM-6240

Thu
07
Mar 2019

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