3D Tissue Models
Products Used in Early Phase IND Studies

Fremont, CA
Good Manufacturing Practises, gmp compliance courses, gmp good manufacturing practice trainings, 2018 Online Webinars, advanced trainings in USA

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 

What to do at really early stages
What about special IND studies?
What about preclinical studies?

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

Speaker Profile:
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 .

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Schedule of Presentations:

Friday, January 19, 2018
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