May 16, 2018 | 10:00 AM | Wednesday

Event Location

Fremont

Online, Fremont, CA 94539

Neighborhood: Upper West Side

Description

How it may be integrated with the recommendations of the guidance documents on CMC requirements.


Start on : May 16, 2018 10:00 AM Wednesday
End on : May 16, 2018 11:15 AM Wednesday

Event Details

Overview:
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 preclinistudies?

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

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.

Event Fee: One Dial-in One Attendee Price: US$150.00

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

Expectations for Products Used in Early Phase

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