Raps Pre-approved Webinar On gmp Expectations For Products Used In Early Phase Ind Studies.
Description:
Description:
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:
oDiscussion of the elements found in the guidance document for Phase 1 material.
oWhat to do at really early stages.
oWhat about special IND studies?
oWhat about preclinical studies?
oVarying GMP activities that depend upon the nature of the IND product
oWhat are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?
oWhat to do about QC activities such as instrument qualification, method validation, and process validation.
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When:December 18, 10:00 AM PDT | 01:00 PM EDT
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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.
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For whom:
The webinar will benefit
oRegulatory Affairs personnel who coordinate activities for the CMC sections of submissions
oQA/QC personnel who need to plan work on early stage material
oR & D personnel who will contribute data to CMC sections
oProject managers for product development studies
oQuality systems auditors
oConsultants
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Duration: 90 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407
by: GlobalCompliancePanel
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