ComplianceOnline

Validation of Computerized Analytical Systems

Instructor: Dr. Ludwig Huber
Product ID: 700212
Training Level: Advanced
  • Duration: 60 Min

recorded version

$249.00
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

$500.00
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

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

Why Should you Attend:

Laboratory systems are amongst key targets of FDA inspections. They are considered high risk systems because they can have a high impact on product quality. Validation can be a challenge because laboratory computers become more and more automated. And automated systems are more and more networked so the question is how to validate networks. Last but not least programs are readily available for customization such as Macro programs and spreadsheet applications, they need to be validated, too. This seminar will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

What Attendees will Learn:

  • FDA and EU requirements for laboratory computers - What do inspectors ask and what documents should be available
  • Most frequently cited deviations related to laboratory computers
  • How to develop a validation master plan for laboratory computers?
  • How to write a user requirement specification document?
  • Validation steps: DQ/IQ/OQ/PQ
  • Recommendations for risk based validation
  • How to ensure and validate spreadsheet integrity
  • How to ensure system security and data integrity
  • Qualification of laboratory network infrastructure
  • Qualification of laboratory network infrastructure
  • Validation of networked systems
  • How to document planning, specifications, installation, testing and changes

Additional benefits:

Attendees will receive:

  • SOP: Validation of Laboratory Computer Systems
  • Checklists/Gap Analysis: Laboratory computers 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:

  • Lab Supervisors and Managers
  • QA managers and personnel
  • Internal auditors
  • Analysts
  • IT managers and personnel
  • Consultants
  • Teachers

Instructor ProfileL:

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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Product Reviews Write review

The teleconference was very good.Transmission/pictures were good.
- Anonymous

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