RAPS pre-approved webinar on "Cost-Effective Computer System Validation: Step-by-Step" from GlobalCompliancePanel

Top Quote GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, "Cost-Effective Computer System Validation: Step-by-Step" on December 13. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion. End Quote
  • Fresno, CA (1888PressRelease) December 13, 2012 - 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:

    o SOPs: Validation of Commercial Off-the-Shelf Computer Systems
    o Checklist: Using computers in FDA regulated environments
    o Validation examples from planning to reporting

    This training session will cover the following areas:
    o US FDA and EU requirements and enforcement practices
    o Learning from recent FDA 483's and warning letters
    o Selecting the right validation model: qualification vs. verification
    o Eight fundamental steps for computer system validation
    o Structure and example of a validation plan
    o Justification and documentation of risk levels
    o Example qualification document for suppliers of commercial systems
    o Examples for requirement and functional specifications
    o Example for IQ protocols
    o OQ test protocols: development, execution, approval - examples
    o Documentation of ongoing performance
    o Validation of existing systems
    o Structure and example of a validation report
    o Step-by-step case studies from laboratories and manufacturing for easy implementation

    When:December 13, 10:00 AM PDT | 01:00 PM EDT
    By whom:
    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.

    For whom:
    This webinar will benefit
    o IT Managers and System Administrators
    o QA Managers and Personnel
    o QC and Lab Managers
    o Validation Specialists
    o Regulatory Affairs
    o Training Departments
    o Documentation Department
    o Consultants

    Duration:75 minutes
    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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