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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.
8 results Found
Live Webinar
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate & Advanced
- 120 Mins
- Dec 10, 2024
Live Webinar
Data Integrity and Privacy - 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 Regulat ...
- Basic & Intermediate & Advanced
- 90 Mins
- Jan 22, 2025
Live Webinar
Excel Spreadsheets; develop and validate for 21 CFR Part 11 compliance
This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand ho ...
- Basic & Intermediate & Advanced
- 75 Mins
- Feb 04, 2025
Live Webinar
The 6 Most Common Problems in FDA Software Validation and Verification
This training on FDA software validation and verification will provide you with the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
- Basic & Intermediate & Advanced
- 120 Mins
- Mar 10, 2025