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MEDICAL SPECIALTIES ...

Products Used in Early Phase IND Studies

From Friday, January, 19, 2018 to Friday, January, 19, 2018 in CA
Starting from:10:00
Concerned sectors: Biotechnology -Medical Informatics -
DESCRIPTION
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
PUBLIC, SECTORS, ACCREDITATION
Accreditations: 0
Concerned Public: General public
Attendance: International
Visitors/Participants: 100
Speakers: 1
Exhibitor: n.c
Event Type: Online Conference
Major Sector: BIOTECHNOLOGY
Concerned sectors: Biotechnology -Medical Informatics -
ORGANIZER / ADVERTISER

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congress, conferences or medical training REF #28-7703
Products Used in Early Phase IND Studies
Published on congres-medical.com on:2017-11-14 13:47:29
Congress, conferences or medical training in BIOTECHNOLOGY
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