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.

Website

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: 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.




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