161 Mission Falls Lane, Suite 216,,

Fremont,

California,

USA,

ZIP: 94539

Phone: 8004479407

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: [email protected]