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

The Most Common Problems with Software Validation Processes

Speaker will also provide the details for company compliance including GAMP, qualification, and validation. It teaches the Part 11 industry standards for SOPs, security, data transfer, audit trails, and electronic signatures. The webinar details the common problems and how to avoid them.

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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. This webinar demystifies Part 11 and the new European equivalent Annex 11. It gets you on the right track for using electronic records and signatures to greatly increase productivity.

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Speakers

Software Validation Planning for Executives and Managers

This webinar is intended for executives and managers, and explains the business fundamentals of regulatory compliance. It explains what does and does not need to be validated. It describes exactly what is required for compliance with 21 CFR Part 11.

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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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Speakers

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.

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