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  Home > Speaker Profile

Speaker Profile


Steven S Kuwahara
Founder & Principal, GXP Biotechnology, LLC

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 . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.
Upcoming Webinars
No Live Webinars found.

Recorded Webinars
GMP for Phase 1 Products
This presentation will cover the contents of the guidance that was given.
Recorded ,
$295.00
GMP Perspectives on Working with Contracting Laboratories
This presentation will cover the responsibilities of both parties, and the procedures for assuring that responsibilities are met.
Recorded ,
$295.00
Statistical Procedures Needed for Compliance with the New Draft Guidance on Process Validation
This guidance document contains several statements that make it clear that statistical procedures will be expected.
Recorded ,  Duration:75 Minutes
$295.00
Understanding Analytical Test Results: Comparing Two Sets of Data
The class will cover the understanding the properties of single test results and how they may be compared.
Recorded ,
$295.00
GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products.
Recorded ,
$295.00
Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required.
Recorded ,
$295.00
Risk Analysis in Pharmaceutical Manufacturing: A Regulatory Overview
The issue of risk management or risk assessment is becoming an important tool for decision making in the pharmaceutical industry.
Recorded ,
$295.00
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