RAPS pre-approved webinar on "GMP Expectations for Products Used in Early Phase IND Studies" from GlobalCompliancePanel

Top Quote "GMP Expectations for Products Used in Early Phase IND Studies" is the topic of a 90-minute, RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on December 18. This webinar, at which Steven S. Kuwahara, Founder and Principal, GXP BioTechnology LLC, will be the speaker. End Quote
  • Fresno, CA (1888PressRelease) December 18, 2012 - The FDA's recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexity early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I.

    Although these new guidelines appear to remove the need to followGMPs for Phase I products; the same still exists in the Food, Drug, and Cosmetic Act. As a result, the need for GMP requirements for Phase I products has not been done away with; rather, it has been altered. Now, the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned.

    This presentation will review the GMP guidance document and discuss how it may be integrated with the recommendations of the guidance documents on CMC requirements. It will cover the following areas:

    o Discussion of the elements found in the guidance document for Phase 1 material.
    o What to do at really early stages.
    o What about special IND studies?
    o What about preclinical studies?
    o Varying GMP activities that depend upon the nature of the IND product
    o What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
    o What to do about QC activities such as instrument qualification, method validation, and process validation.

    When:December 18, 10:00 AM PDT | 01:00 PM EDT

    By whom:
    Steven S. Kuwahara, Ph.D., is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. After securing degrees in Biochemistry from Cornell and the University of Wisconsin, Steven started off as an Assistant Professor of Chemistry.

    His testing skills were honed in the initial years of his career at the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here, he developed expertise in the testing of blood derivatives, viral and bacterial vaccines. His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors.

    During an impressive career spanning over 30 years, Steven has applied his academic knowledge to quality control in the pharmaceutical industry. Steven has written several papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

    For whom:
    The webinar will benefit

    o Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions
    o QA/QC personnel who need to plan work on early stage material
    o R & D personnel who will contribute data to CMC sections
    o Project managers for product development studies
    o Quality systems auditors
    o Consultants

    Duration: 90 minutes

    To enroll for this webinar, contact
    webinars ( @ ) globalcompliancepanel dot com
    Phone: 800-447-9407

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