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Recorded Steven S Kuwahara GMP for Phase 1 Products This presentation will cover the contents of the guidance that was given. Recorded View Anytime $295.00 Steven S Kuwahara 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 View Anytime $295.00 Steven S Kuwahara Auditing Analytical Laboratories for FDA Compliance Auditing analytical laboratories can be complex because of the preparation that is often required. Recorded View Anytime $295.00 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. Recorded View Anytime $295.00 Steven S Kuwahara 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 Recorded View Anytime $295.00 Steven S Kuwahara Statistical Procedures Needed for Compliance with the New Draft Guidance on Process Validation This guidance document contains several statements that make it clear that statistical procedures will be expected.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 View Anytime  Duration:75 Minutes $295.00 Steven S Kuwahara 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 View Anytime $295.00 << >>