Speaker Profile

David Nettleton
FDA Compliance Specialist,

David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.

Speakers

21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits

This webinar details both regulations and provides details for implementing computerized systems. Learn exactly what is needed to be compliant for all three primary compliance areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.

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Speakers

Excel Spreadsheet Validation To Eliminate 483s

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

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Speakers

Efficient Computer System Validation - 10 Easy Steps

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.

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GxP Computer System Validation, The investigator's Point of View

The webinar explains what is needed to prepare for an audit or regulatory inspection. It addresses SOPs for the GxP and IT infrastructure, hardware and software qualification, computer system validation, and change control for revalidation. This event is applicable to regulated companies and software vendors.

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Speakers

Excel Spreadsheet Validation To Eliminate 483s

This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

View Details










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