Date : Tuesday, November 16, 2010
Time : 10:00 AM PDT | 01:00 PM EDT
Duration : 75 Minutes GMP Expectations for Products Used in
Early Phase IND Studies
Price : $245.00
Overview: FDA issued a guidance document covering GMP
requirements for Phase 1 products. These guidelines remove Register Now
some of the problems that are encountered with early phase
products and are in addition to those that cover the CMC Instructor Profile:
sections for IND submissions at Phase 1. Although the
Steven S Kuwahara
guidance appears to remove the need to follow GMPs for
Founder & Principal, GXP
Phase 1 products, the need to follow GMPs is still present in Biotechnology, LLC
the Food, Drug, and Cosmetic Act. Thus the nature and extent
Steven S. Kuwahara, Ph.D. is the
of GMP-related activities will depend upon the nature of the
founder and Principal of GXP
investigational drug and the extent of the study that is
BioTechnology LLC, a consulting firm
planned. This presentation will review the GMP guidance
that works in the areas covered by
document and discuss how it may be integrated with the
the GLP and GMP of drugs, biologics,
recommendations of the guidance documents on CMC
and nutraceuticals. Steve has over
30 years of experience in supervising
quality control laboratories, including
Areas Covered in the Session: an animal testing facility, and in
performing GLP and GMP audits of
l Discussion of the elements found in the guidance internal and external testing
document for Phase 1 material. laboratories . Steve has participated
l What to do at really early stages. in the development of drugs and
l What about special IND studies? biologicals through all phases of
l What about preclinical studies? clinical research and final product
l Varying GMP activities that depend upon the nature of production. ...more
the IND product.
l What are the requirements for the GMP found in the
Food, Drug, and Cosmetic Act?
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l What to do about QC activities such as instrument
Your Necessity is our Priority
qualification, method validation, and process validation.
Click here to register for this webinar
Who Will Benefit:
l Regulatory Affairs personnel who coordinate activities
for the CMC sections of submissions.
l QA/QC personnel who need to plan work on early
l R & D personnel who will contribute data to CMC
l Project managers for product development studies.
l Quality systems auditors
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit
from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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