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Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.



Is your Laboratory Information Management System (LIMS) in compliance with 21 CFR Part 11 Subpart B - Electronic Records?

Global CompliancePanel
Global CompliancePanel
Training Options
 Duration: 60 Minutes  
Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
Global CompliancePanel
Global CompliancePanel
Customer Testimonials
Instructor Bernice Russell Bond
Product Id 600037

Overview: This webinar has been developed to provide clarification and interpretation on how to use LIMS in compliance with FDA Electronic Signatures and Electronic Records Rules.

For laboratories typically processing large numbers of samples every day, information management is a critical task. With a growing workload in the laboratory, the chances for errors of omission and data transcription increase, as does the amount of time devoted to paperwork, unnecessary duplication and rework.

Additionally, periodic review and analysis of the progress and quality of laboratory work becomes increasingly important. In fact, a laboratory can be only as good as its ability to manage its final product - the information it produces.

Laboratory productivity, accuracy and control are usually greatly increased with improved information processing capabilities.

Areas Covered in the Session:

  • Define LIMS
  • Benefit of LIMS
  • LIMS Functionality
  • Quality Assurance
  • Lifecycle of samples
  • Compliance and Validation

Who will Benefit:

  • Quality system auditors
  • All Quality/Compliance Managers at sites with LIMS
  • All System Owners of LIMS
  • All users of LIMS



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