Change Control for Computer Systems - strategies and tools for FDA compliance


Instructor: Dr. Ludwig Huber
Product ID: 700078
Training Level: Advanced

  • Duration: 60 Min
This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.


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Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
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Why Should You Attend:

It is well known that most problems of software, computer systems and networks are introduced when changes are made, either during development or during use of the systems. Inadequate documentation of changes and testing after changes is one of the most frequently cited deviations during FDA inspections. Users of the system, system owners and network administrators are unsure on how to document initial set-up and manage changes. This seminar will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.

What participants will learn:

  • US FDA and EU requirements for change control
  • Defining configuration management versus change control and change management
  • The IEEE model for configuration management and change control
  • Reviewing a change control procedure
  • Change control for hardware, operating systems, and application software
  • The change control process for planned and unplanned changes
  • Versioning of software and computer systems
  • What to test after changes
  • How to document changes
  • Learning through examples
    • Computer hardware, firmware
    • Software (operating system, applications, security patches)
    • Networks (server, client, router)
    • Documentation (specifications)

Who Should Attend:

  • Everybody involved in software and computer system validation
  • IT Administrators
  • QA managers and personnel
  • Validation specialists
  • Suppliers of software and computer systems
  • Regulatory affairs
  • Training department
  • Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is Compliance Program Manager at Agilent Technologies. He is the editor of, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books "Computer System Validation", "Network Quality Package" , and "Validation of Computerized Analytical and Networked Systems".For more information, visit Dr. Huber's website:

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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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