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    Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

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    Website https://www.complianceonline.com/bacterial-endotoxin-test-to-include-the-latest-on-low-endotoxin-rec | Want to Edit it Edit Freely

    Category

    Deadline: May 29, 2022 | Date: June 07, 2022

    Venue/Country: Online Event, U.S.A

    Updated: 2022-05-06 00:44:12 (GMT+9)

    Call For Papers - CFP

    The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

    Why Should You Attend:

    The objective of this interactive webinar is to explore the new Guidance for Industry on Pyrogen and Endotoxins Testing which addresses those issues that may be subject to misinterpretation, and are not covered in compendial procedures or in the currently available Guidance documents and how they impact testing within the typical Quality Control laboratory. It will also discuss the results of Low Endotoxin Recovery (LER).

    Areas Covered in the Webinar:

    Review of the current testing requirements to include Low Endotoxin Recovery (LER)

    What happened to the old 87/91 LAL Guidance for Industry Document

    What has replaced it and why

    Common issues, misunderstandings and misinterpretations

    Determine who comprise the Agency Guidance team within this new proposed Guidance

    Documents supporting this new Guidance

    Sampling, storage, handling and pooling

    How does transition happen from one bacterial endotoxin test to another

    Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL

    The FDA's expectation for screening of therapeutic products


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.