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Expectations for Products Used in Early Phase


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Who should attend?

Project Managers for Product Development Studies Quality Systems Auditors Consultants

Details

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

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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