Generic placeholder image

David Nettleton

David Nettleton is a keynote speaker of ComplianceKey. Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (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 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-n-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 virtualized environments.

David Nettleton is also the co-author of:
  • Managing the Documentation Maze - Answers to Questions You Didn't Even Know to Ask (Wiley - www.wiley.com)2010
  • Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com, 2004)
  • Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org, 2003).

 Webinar Id: LSHCDN002
10:00 AM PT | 01:00 PM ET
 05/23/2019
 Duration 60 mins

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

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the ........


View Details

                $179
       Single Attendee
(Only for one Participant)
          $368
Multiple Attendee
( 2 - 5 Participants)
          $741
Corporate Attendee
( 6 - 10 Participants)
                   $167
         Recorded
(6 months unlimited access)



Insert title here
Pay Pal Logo   PayPal Verified Logo   GoDaddy Certified
Copyright © 2018 Compliance Key . All Rights Reserved. Back to Top