Conference Description:

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]