OCT 23, 2020 7:00 AM PDT

Quality Control Electronic Records for 21CFR part 11 Data Integrity

Speaker
  • Senior Marketing Manager, Beckman Coulter
    Biography
      Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents. Tony was joint editor on the ISPE Guide to Ozone Sanitization of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring. Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.

    Abstract

    DATE:  October 23, 2020

    TIME:   07:00am PDT, 10:00am EDT

     

    The FDA’s 21CFR part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures for Quality Control testing and manual transcription of the test results still common practices in the pharmaceutical QC world, the resultant opportunities for human error raises concerns over the integrity of the data in the final electronic record, no matter how safely the final record is stored. This presentation describes how Quality Control instruments can be optimized for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.

     

    The webinar will help cleanroom users understand the following:

    • Learn about applying the Compendial tests for Water For Injection, Cleanroom Environmental Monitoring and Sub-visible Particulate testing for Parenteral Products
    • Understand the challenges manual QC Standard Operating Procedures pose to 21CFR part 11 data integrity
    • Learn how Beckman Coulter suite of QC Instrumentation are optimized and automated to reduce human error and improve 21CFR part 11 data integrity.

     

    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


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