JUN 23, 2021 8:00 AM PDT
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A well-implemented LIMS = good data integrity

Sponsored by: Sartorius
C.E. Credits: P.A.C.E. CE Florida CE
Speaker
  • Lead Consultant, Segalstad Consulting AS
    Biography
      Siri H. Segalstad has worked with validation of IT systems in the pharmaceutical and other regulated industries since 1988. She has worked with accredited laboratories and knows the ISO 17025 standard very well. She was approved as an auditor for Norwegian Accreditation in 1998. She has also written the book "International IT Regulations and Compliance", Wiley 2008 which covers all aspects of IT regulations and validation. She is the lead consultant in Segalstad Consulting AS, Norway. She has been teaching this in classes at Pittcon, Dubai and other places for many years with good feedbacks from the participants.

    Abstract
    Date:  June 23, 2021
    Time: 8:00am (PDT),  11:00am (EDT)
     
    Data integrity with its "ALCOA+" is the new buzz-word. But what is it, really? And how do we get there? The presentation will first clarify what data integrity is, with the explanation of ALCOA+ terminology. Then the difficult question about how to achieve data integrity. The best tool is a LIMS, but only if it has been implemented in a good way. The presentation will continue showing many examples of good (and bad) ways to implement the LIMS for good data integrity.
     
    Learning Objectives
    • State which standards apply, and interpret the current standards for data integrity in the regulated environments
    • Demonstrate how a LIMS can help with data integrity in the lab.
    • Outline how a LIMS should be implemented in order to fulfill the data integrity requirements.
    • Assess the changes needed to be done, to achieve better data integrity, even if they don’t have a LIMS
     
     
    Webinars will be available for unlimited on-demand viewing after live event.
     
    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.

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