OCT 23, 2020 7:00 AM PDT

Quality Control Electronic Records for 21CFR part 11 Data Integrity


Event Date & Time

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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