Beckman Coulter Webinar on Optimizing QC Electronic Records for 21 CFR Part 11 Compliance
Yorba Linda, CA (PRWEB) August 24, 2016 -- Guidance from the Food and Drug Administration (FDA) on the use of electronic records for data retention or submission, namely, part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11), is quite clear. This does not in itself remove human error from the equation. As manually implemented Standard Operating Procedures for Quality Control (QC) testing and manual transcription of the test results are common practices in pharmaceutical QC operations, the risk of human error raises questions about the integrity of the data in the final electronic record, regardless of how safely the record itself is stored.
Beckman Coulter Life Sciences is sponsoring a new, free educational webinar, “Optimizing Quality Control Electronic Records for 21 CFR Part 11 Compliance,” which will discuss how QC instruments can be optimized for pharmaceutical use, helping to improve the integrity of the data in electronic records.
The speaker is Tony Harrison, a senior marketing manager at Beckman Coulter. Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms. He is the UK subject-matter expert for the ISO Working Group in the midst of revising ISO 14644-1 & -2 for cleanroom classification at the core of the aseptic manufacturing chapters of the European GMP and USA cGMP documents. Experienced in water system total organic carbon (TOC), conductivity and ozone analysis, cleanroom monitoring systems, and particle characterization, Tony has spent the past 12 years in applied metrology for the pharma and healthcare manufacturing industries. He has a bachelor’s degree in electrical and electronic engineering. Tony’s complete bio is found on the LabRoots website.
The free webinar, hosted by LabRoots, will be presented on September 8, 2016, at 8 am PST/11 am EST.
For full details about the event and free registration, click here.
About Beckman Coulter:
Beckman Coulter serves customers in two segments: Diagnostics and Life Sciences. The company develops, manufactures, and markets products that simplify, automate, and innovate complex biomedical testing. More than 275,000 Beckman Coulter systems operate in both Diagnostics and Life Sciences laboratories on seven continents. Scientists use Beckman Coulter’s Life Science research instruments to study complex biological problems, including causes of disease and potential new therapies or drugs.
About LabRoots:
LabRoots is the leading scientific social networking website and producer of educational virtual events and webinars. Contributing to the advancement of science through content sharing capabilities, LabRoots is a powerful advocate in amplifying global networks and communities. Founded in 2008, LabRoots emphasizes digital innovation in scientific collaboration and learning, and is a primary source for current scientific news, webinars, virtual conferences, and more. LabRoots has grown into the world’s largest series of virtual events within the Life Sciences and Clinical Diagnostics community.
Rachel Ashton, LabRoots, Inc., http://www.LabRoots.com, +1 (530) 386-6101, [email protected]
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