ECA - The new FDA Approach to Analytical Methods Validation of Drugs and Biopharmaceuticals

Art-No.: A-1077
Date: 24-25 November 2014

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
13343Analytical Methods Validation - sources of variability and error055
13344How to apply statistical analysis and models in analytical methods validation053
13345Validation for MAA/NDA: Planning and Execution053
13346Lifecycle Management of analytical procedures: method development, procedure performance qualification and procedure performance verification030
13347How to apply the principles of the FDA Guidance to Biopharmaceuticals - Case Studies00
13348Workshop: Critique of analytical documents in the lifecycle03
13349Analytical Method Comparability Studies056
13350Robustness, Ruggedness and System Suitability Tests045
13351Biological Reference Standards and Materials00
13352FDA's Regulatory expectations concerning analytical procedures00

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