Risk Based Validation of Software and Computer Systems

Instructor: Dr. Ludwig Huber
Product ID: 700339
Training Level: Advanced
  • Duration: 60 Min

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
Last Recorded Date: Apr-2007

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


Read Frequently Asked Questions

In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.

Why Should You Attend:

Recent FDA and industry guidances recommend to base the extent of validation of computer systems and other controls on risk assessment. Examples are FDA’s Part guidance, GAMP4, ISO and ICH Q9. Frequently risk categories are easy to define but the real challenge comes when users should take action to optimize risks versus costs. In this interactive web seminar we will go through various scenarios and recommend actions for validation and other controls.

What Attendees will Learn:

  • FDA/EU and business requirements
  • Guidance from regulatory and industry task forces: ISO, ICH, GHTF, NIST, GAMP/ISPE
  • Practical approach for risk assessments
  • How to develop a risk based software and computer validation program
  • Validation tasks for risk categories for each life cycle phase- Planning, design and specifications, vendor assessment, installation, testing, change control, back-up, contingency planning
  • Validation tasks segmented by system complexity
  • Documenting the decision for management and for the FDA
  • Examples and specific recommendations from laboratories, office computers and production

Additional benefits:

Attendees will receive presenter’s:

  • Risk Management Master Plan
  • SOPs: Risk assessment Used for GxP Environments
  • SOP: Risk-based Validation of Computer Systems

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

Who Will Benefit:

  • Validation specialists
  • IT specialists
  • QA managers and personnel
  • Software developers
  • Users of software and computer systems
  • Regulatory affairs
  • Training department
  • Documentation 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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Seminars by Ex-FDA Officials
Critical Vendor Risk Management

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.

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Product Reviews Write review

The presentation gave useful, real life examplesa definite plus.
- Anonymous

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