Expectations for Products Used in Early Phase

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Category GMP Expectations for Products, IND submissions, gmp manufacturing, cgmp training Online, quality compliance systems, regulatory compliance in healthcare, fda compliance training

Deadline: May 15, 2018 | Date: May 16, 2018

Venue/Country: Online, U.S.A

Updated: 2018-03-20 14:58:23 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com