ALTHOUGH THE GUIDANCE APPEARS TO REMOVE THE NEED T 2013 - GMP Expectations for Products Used in Early Phase IND Studies - Webinar By GlobalCompliancePanel

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Category Webinar, Health, Medical, Pharma, Clinical

Deadline: July 16, 2013 | Date: July 16, 2013

Venue/Country: Fremont,CA, U.S.A

Updated: 2013-07-02 20:00:27 (GMT+9)

Call For Papers - CFP

Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus 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.

Areas Covered in the Session:

Discussion of the elements found in the guidance document for Phase 1 material.

What to do at really early stages.

What about special IND studies?

What about preclinical studies?

Varying GMP activities that depend upon the nature of the IND product.

What are the requirements for the GMP found in the Food, Drug, and Cosmetic Act?

What to do about QC activities such as instrument qualification, method validation, and process validation.

Who Will Benefit:

Regulatory Affairs personnel who coordinate activities for the CMC sections of submissions.

QA/QC personnel who need to plan work on early stage material

R & D personnel who will contribute data to CMC sections.

Project managers for product development studies.

Quality systems auditors

Consultants

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. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories .

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

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http://www.globalcompliancepanel.com

Event Link - http://bit.ly/18sesXx