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Nice response to my questions and good suggestions for moving forward.
Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,
I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.
Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

 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
Auditing Analytical Laboratories for FDA Compliance
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted.
Live  Tuesday, June 11, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:90 Minutes
$245.00
GMP Expectations for Products Used in Early Phase IND Studies
FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.
Live  Tuesday, July 16, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:75 Minutes
$245.00
...more
 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
...more


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