May 16, 2018 | 10:00 AM | Wednesday
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
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
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
Compliance4All DBA NetZealous,
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