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Leachables Testing in a GMP Environment: Introducing the Agilent Infinity Lab LC/MSD XT. Instrument Overview and Case Study
June 27, 2017
First Session: USA 9:00 a.m. EDT / 6:00 a.m. PDT / 14:00 BST / 15:00 CEST
Repeat Session: USA 12:00 p.m. EDT / 9:00 a.m. PDT / 17:00 BST / 18:00 CEST
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Overview
Manufacturers of pharmaceuticals have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify low level extractable and leachable compounds (E&Ls), which may be potentially toxic or have otherwise undesirable effects on the efficacy of drugs.
At this webinar, we will present a leachables study on an ophthalmic drug product analyzing both targeted and suspected leachables with the new Infinity Lab LC/MSD XT system operated with OpenLAB CDS, and enabling 21 CFR Part 11 compliance. OpenLAB CDS Software enables critical compliance features such as audit trails, e-signatures, and provides confident data integrity for your GMP analyses. The instrument is ideally suited for demanding applications where detection of low levels of leachables is required, delivering high sensitivity and fast polarity switching, within a compact footprint ideally suited for a GMP environment. The application provided quantitative information for leachables found to be above Analytical Evaluation Threshold (AET) levels as calculated by the built-in custom calculator in OpenLAB CDS.
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Particpants Will Learn:
• What's new with the InfinityLab LC/MSD XT? Why is this instrument ideally suited for GMP analyses?
• How does the OpenLAB CDS workflow enable your GMP analyses better than any other commercially available product in its class?
• About the fully automated suspect screening, target screening and quantitative workflows leading to automated final report generation.
• About unique features such as browsing through results from multiple lots using Peak Viewer, fully integrated calculations and AET threshold setting using Customer Calculator, In built UV and MS library creation and automated library matching, confident quantitation and many others.
Who Should Attend:
• Pharmaceutical QC analysts and QC Lab managers
• Researchers interested in Leachables Testing in Food/Pharma/Medical Device/Consumer Products/Polymer Manufacturing/CRO's/CMO's and other
• Quality Assurance experts in above industries
Speakers
Single Quadrupole Product Manager,
GC/MS & LC/MS,
Agilent Technologies, Inc.
Applications Engineer,
Agilent Technologies, Inc.
Global Pharma Segment Marketing Manager,
Agilent Technologies, Inc.
Moderator
Senior Editor,
C&EN
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