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Customer Testimonials
Nice response to my questions and good suggestions for moving forward.
Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,
I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.
Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

 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.
 Upcoming Webinars
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.
Live  Tuesday, June 18, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
Ten-Step Process for COTS Computer System Validation - Reduce Time and Costs
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.
Live  Tuesday, July 2, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
Excel Spreadsheets - Develop and Validate to Eliminate 483s
Learn how to Use excel spreadsheet for GXP data and reduce validation cost and time. Configure Excel for audit trails, security features, and data entry verification.
Live  Thursday, July 18, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$245.00
...more
 Recorded Webinars
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.
Recorded  Wednesday, March 10, 2010 11:00 AM PST | 02:00 PM EST,  Duration:75 Minutes
$295.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This webinar details the regulation and how it applies to computerized systems.
Recorded  Wednesday, March 10, 2010 11:00 AM PST | 02:00 PM EST,  Duration:75 Minutes
$295.00
Computer Systems Used in Clinical Trials
This interactive webinar provides an overview of techniques used for buying, deploying, validating, and maintaining computer systems used for clinical trials.
Recorded ,
$295.00
Excel Spreadsheets – Step-By-Step Instructions for Compliance
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.
Recorded ,
$295.00
...more


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