Computer System Validation: Step-by-Step
Date & Time: Thursday, January 26, 2012
10:00 AM PST | 01:00 PM EST
Duration: 90 Minutes
Instructor: Dr. Ludwig Huber
Price : $245.00
(for one participant)
Reference material for easy implementation:
Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies
This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. ...more
The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols.
SOPs: Validation of Commercial Off-the-Shelf Computer Systems Checklist: Using computers in FDA regulated environments
Validation templates and examples
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Your Necessity is our Priority
Areas Covered in the Session: l l l
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US FDA and EU requirements and enforcement practices Learning from recent FDA 483's and warning letters Selecting the right validation model: qualification vs. verification
Eight fundamental steps for computer system validation Structure and example of a validation plan Justification and documentation of risk levels Example qualification document for suppliers of commercial systems Examples for requirement and functional specifications? Example for IQ protocols OQ test protocols: development, execution, approval examples Documentation of ongoing performance Validation of existing systems Structure and example of a validation report Step-by-step case studies from laboratories and manufacturing for easy implementation
Click here to register for this webinar Who Will Benefit: l l l l l l l l
IT managers and system administrators QA managers and personnel QC and Lab managers Validation specialists Regulatory affairs Training departments Documentation department Consultants
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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Published on Dec 20, 2011
This webinar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implemen...