Systems Validation Made Easy

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This webinar will discuss the Part 11 requirements and practical techniques for evaluation of the current compliance status of a given organization. You will hear about validation requirements, system security protocols, rules for building computer networks, adding new components to network, back-up of data, access control, rules for passwords, and audit trails. Case studies will be used to highlight common issues and potential solutions.

21 CFR Part 11 describes the quality standards required of all computer systems used in FDA-regulated industry. This regulation provides the basic framework for computer systems used to generate records and data used for analysis and presentation. However, for any organization trying to understand and implement Part 11 requirements, there are only two options: One, hire expensive consultants and purchase expensive software, or implement self-created systems and live in constant fear of findings of non-compliance during FDA audits. In this seminar, we will simplify the regulatory requirements and add practical tips for quick and easy verification of compliance with FDA requirements which can be self-implemented by most organizations with minimum technical expertise.

Areas to be Covered:

Part 11 requirements by FDA
Applicable systems per the FDA
Validation of computer systems
Network set-up, maintenance, integrity check and security
Common elements of Part 11 complaint computer systems
Building Part 11 compliant systems bottom-up and top-down.
Back-up and re-creating data
Verifiable audit trails
Electronic signatures and certificates
Best practices for using non-networked computers

Who will Benefit:

This webinar will provide valuable information to:

FDA-regulated labs, clinical trial sites, manufacturers, and sponsors
Everyone involved in computer system validation
Anyone selecting computer systems intended for FDA regulated environments
Information technology professionals responsible for files or network locations
Quality professionals who organize, document and verify system compliance
Executives evaluating requirements Part 11 compliant systems

Herman Wong

Herman Wong is a Washington DC-based consultant for computer systems in FDA-regulated industry. He has been in the industry for over 12 years and is the Director of the Information Technology department at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in training of IT personnel in FDA-regulated industry, creating, managing and implementing Part 11 compliant computer systems. Since 2005, Mr. Wong has been evaluating EDC systems for Part 11 compliance at small and big organizations including some of the largest US federal organizations and large pharmaceutical companies.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance