
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.
Spreadsheets are everywhere in GxP work, and poorly controlled ones lead to FDA 483s. This interactive 75-minute webinar shows how to develop and validate Excel spreadsheets for 21 CFR Part 11 com…
Industry: FDA Compliance Duration: 75 Minutes Time: 10:00 AM PDT | 01:00 PM EDT
As manufacturing and quality systems rely more on software, exposure grows, and most recalls can be traced back to computerized equipment. This 120-minute FDA software validation webinar walks thr…
Industry: FDA Compliance Duration: 120 Minutes