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Validation of Bioanalytical Methods and Procedures for FDA Compliance
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This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.
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Instructor : Dr. Ludwig Huber
Live
Wednesday, March 14, 2012
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Full-day Virtual Seminar: Validation of Analytical Procedures for Use in the Pharmaceutical Industry
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This 6-hr virtual seminar will review analytical procedures used in assessing quality, safety and efficacy of drug products. It will cover the ICH and USP guidelines for procedure validation and help you ensure robust validation of analytical procedures for drug substances and products.
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Instructor : Barbara Berglund
Live
Friday, February 24, 2012
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Leaping into Lab: Everything about Waived Testing
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This CLIA Webinar training will feature an in-depth look at CLIA Waived Testing. It will present the rules and regulations as well as the pros and cons of testing using Waived methods.
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Instructor : Barry Craig
Live
Friday, February 24, 2012
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How to prepare for and survive a CLIA inspection - Clinical Laboratories Improvement Act
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In this CLIA inspection webinar understand how to get your lab ready for inspection, what the inspectors will look for and how to do inspection follow up and response.
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Instructor : Barry Craig
OnDemand
Access Anytime
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CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
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This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.
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Instructor : Barry Craig
OnDemand
Access Anytime
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Designing appropriate product specifications for parenteral products
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This webinar will focus on defining the appropriate procedures and establishing appropriate specification limits for lyophilized sterile parenteral products.
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Instructor : Barbara Berglund
OnDemand
Access Anytime
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Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation
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The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application.
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Instructor : Barry Craig
OnDemand
Access Anytime
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Bioanalytical Methods Validation
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In this Bioanalytical methods validation understand the Clear, Consistent and compliant approaches for instrumental, ligand binding, and cell based methods.
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Instructor : Edward O Connor
OnDemand
Access Anytime
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Approaching unknown cause laboratory investigations for pharmaceutical products using lean tools
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Understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.
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Instructor : Barbara Berglund
OnDemand
Access Anytime
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