'Method transfer' presentation slideshows

Supplementary Training Modules on Good Manufacturing Practice

Validation Part 4: QC-related validation. Supplementary Training Modules on Good Manufacturing Practice. Validation. Introduction Why is analytical monitoring necessary? What is the purpose of analytical validation?. Validation. Objectives To introduce the concepts of :

333 views • 28 slides

343 views • 21 slides

Analytical Method Development & Validation for Therapeutic Proteins

Analytical Method Development & Validation for Therapeutic Proteins. Jichao (Jay) Kang, Ph.D., RAC Director, Analytical and Formulation Development Gallus Biopharmaceuticals NJ, LLC. Course Objectives. Basic scientific and industrial knowledge of working on proteins (including antibodies)

1.03k views • 12 slides

How To Properly Carry Out An Analytical Method Transfer

Analytical method transfer constitutes a critical step in research as it stimulates drug discovery, clinical testing, and long-term stability testing. Method transfer is achieved to document the fact that a testing laboratory has the qualification of conducting already validated analytical methods for generating GLP compliant.

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Webinar On Transfer of Analytical Methods and Procedures acc

This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.

245 views • 4 slides

To specify the objective of an analytical method transfer.

TRANSFER OF A MULTIDIMENSIONAL ON-LINE SPE-LC-ECD METHOD FOR THE DETERMINATION OF THREE MAJOR CATECHOLAMINES IN NATIVE HUMAN URINE. E. Rozet 1 , R. Morello 2 , W. Dewe 3 , P. Chiap 4 , B. Boulanger 3 , K. S. Boos 2 , J. Crommen 4 and Ph. Hubert 1

135 views • 1 slides