Expectations for Products Used in Early Phase

Start Date : May 16, 2018
End Date : May 16, 2018
Time : 10:00 am to11:15 am

Phone : 18004479407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.




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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/

Event Categories: Health & Nutrition.

Your Review

You must be logged in to post a comment.