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.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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)

Free SOP Templates for Attendees

Attendees will receive the presenter’s SOPs for Change Control and Version Control of software and computer systems and also a set of 6 case studies for planned and unplanned changes.

Note: These complimentary hand-outs will be sent to customers on request. Please email [email protected] for these documents, stating your order number, and they will be emailed to you within 4 working days.

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:

Follow us :
The Drug Development Process from Concept to Market
Data Integrity: FDA/EMA Requirements and Implementation

Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied 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).

Product Reviews Write review

The course was helpful in reviewing change control requirements. I have limited prior experience with computer validation. The examples discussion from other participants was the most beneficial aspect. The opportunity to glean more detailed, technical assessment from an experienced person helps me with my own decision making skills.
- Anonymous

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