Speaker Profile

Steven
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. Steven 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 . Steven has participated in the development of drugs and biologicals through all phases of clinical research and final product production.

Upcoming Webinars Recorded Webinars
  • 17
  • March
  • 2020
  • Tuesday
10:00 AM PDT | 01:00 PM EDT

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required.

Steven S. Kuwahara Steven S. Kuwahara | Duration:90 Minutes | Price: $150.00 | View Details
  • 23
  • April
  • 2020
  • Thursday
10:00 AM PDT | 01:00 PM EDT

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products.

Steven S. Kuwahara Steven S. Kuwahara | Duration:90 Minutes | Price: $150.00 | View Details
Steven S. Kuwahara

GMP Perspectives on Working with Contracting Laboratories

When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $189.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $189.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 75 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

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.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Steven S. Kuwahara

GMP Expectations for Products Used in Early Phase IND Studies

FDA issued a guidance document covering GMP requirements for Phase 1 products.

Speaker: Steven S. Kuwahara | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details