ComplianceOnline

Risk Based Validation of Software and Computer Systems

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

recorded version

$149.00
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

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

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 customercare@complianceonline.com 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 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/

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews Write review

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

Best Sellers
You Recently Viewed
    Loading