subject: cost-effective Computer System Validation: Step-by-step From Globalcompliancepanel [print this page] Description: Description:
Although an FDA requirement for more than two decades; validation of computer systems continues to be companies Achilles Heel. Why this is so is because most companies are strong in terms of grasp of the principles of validation, but are all at sea when it comes to implementation. It is no wonder that they invite FDA Warning Letters, whose rate has gone up in the last three years.
This webinar will offer an easy, step-by-step method of going about validation of computer systems. The need for validation cannot be overstated: Companies stand to save nearly a third of their costs if they could put proper and effective computer system validations which comply with GLP regulations in place.
This webinar will be immensely helpful for those seeking knowledge of how to implement computer system validation that complies with GLP regulations. It is important to note that GLP is also an inspection issue, since compliance training should necessarily include a module on basic GLP knowledge, which everyone working in a GLP environment should carry. This webinar will give participants an understanding of GLP regulations and offer recommendations and tools for implementation.
It will give them these reference materials, which will help them with easy implementation:
oSOPs: Validation of Commercial Off-the-Shelf Computer Systems
oChecklist: Using computers in FDA regulated environments
oValidation examples from planning to reporting
This training session will cover the following areas:
oUS FDA and EU requirements and enforcement practices
oLearning from recent FDA 483's and warning letters
oSelecting the right validation model: qualification vs. verification
oEight fundamental steps for computer system validation
oStructure and example of a validation plan
oJustification and documentation of risk levels
oExample qualification document for suppliers of commercial systems
oExamples for requirement and functional specifications
oExample for IQ protocols
oOQ test protocols: development, execution, approval - examples
oDocumentation of ongoing performance
oValidation of existing systems
oStructure and example of a validation report
oStep-by-step case studies from laboratories and manufacturing for easy implementation
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of many books, including Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems.
He also has more than 100 literature publications and conducts online tutorials regularly. His works speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a renowned expert on not only the FDA but also other regulatory bodies is evident from the fact that he has been Chief Advisor on Global ISO 17025 and FDA Compliance.
