Risk Based Validation of Software and Computer Systems

Speaker

Instructor: Dr. Ludwig Huber
Product ID: 700339
Training Level: Advanced

Location
  • Duration: 60 Min
In this Risk Based Validation training we will go through various scenarios and recommend actions for validation and other controls.
RECORDED TRAINING
Last Recorded Date: Apr-2007

 

$149.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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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

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 http://www.labcompliance.com/, 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: http://www.ludwig-huber.com/

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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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