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    Webinar on FDA New Requirements for Pyrogen and Endotoxin Testing for Drugs, Biologics and Medical Devices

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    Website | Edit Freely

    Category Food, Drugs & Biologics

    Deadline: July 25, 2106 | Date: July 25, 2106

    Venue/Country: Canada

    Updated: 2016-06-30 18:44:50 (GMT+9)

    Call For Papers - CFP

    This presentation will provide great opportunities for industry professionals to be better aware of and rather get more familiar with the current FDA testing requirements for drugs, biologics and medical devices concerning pyrogen and endotoxins testings.

    The speaker will walk you through recent FDA requirements and common misconception for pyrogen and endotoxins testing for drugs, biologics and medical devices.

    Areas Covered in the Session :

    Applicable Laws and Regulations

    Understand FDA’s Recommendations in the Past

    Common Misconception and Misinterpretation

    Current FDA Testing Requirements: Pyrogen and Endotoxins

    Requirements for Sampling, Storage, and Handling

    Monocyte Activation Test (MAT): When and Why

    Rabbit Pyrogen Test: When and Why

    Limulus Amoebocyte Lysate (LAL) Test: When and Why

    Retesting Requirements

    Standards for Consideration

    FDA Enforcement Actions

    Speaker's PASS-IT Suggestions and Recommendations

    Who Will Benefit:

    Regulatory Affairs Departments

    Clinical Affairs Departments

    Quality Assurance Departments

    Compliance Officers

    Radiation Safety Officers

    Laboratory Personnel

    Research & Development Departments



    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.