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Site language : English - Français
Ref : 26172
Event :Products Used in Early Phase IND Studies

Date :Friday January 19th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:
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 preclinical studies?
 
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
Quality systems auditors
Consultants
 
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. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories .
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Products Used in Early Phase IND Studies Pharmacy - Medicine - General medicine - Management
good manufacturing practises, gmp compliance courses, gmp good manufacturing practice trainings, 2018 online webinars, advanced trainings in usa
Professionals, Quality systems auditors Consultants
100 -- --
English

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