Course Description

Biopharmaceutical Analytics: Method Development

This course is currently at capacity or unavailable for registration, please contact Customer Service at (732)613-4500 or for more information.

Course ID 2779

In-Person Course

Who Should Attend?
This course is designed to provide training to biopharmaceutical personnel on analytical method development on an array of different method types commonly used in the Biopharmaceutical Industry. For each method, participants will learn the mechanism of how it works, the reportable data, development techniques, how to trouble shoot and make a method more robust. This course will benefit personnel with experience wishing to deepen their knowledge in method development, or for personnel who are just getting started in analytics. This course is recommended for Quality Control, Analytical Scientist, Research Associates, Product Development, Formulation, and Pre-formulation groups, though any inquiring minds within this industry are welcome to join.

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Course Description
This intensive, 2-day course will teach participants how to develop an array of different analytical methods used in the Biopharmaceutical Industry. Troubleshooting issues during and after development will be discussed for each method as well as practical approaches to strengthening the methods robustness. This accredited course also includes information on how the methods should be used to support manufacturing, regulatory filings and stability programs.

Course Director
Rachel Monsef, Consultant to the pharmaceutical and biopharmaceutical industries

Rachel Monsef is a consultant to the biopharmaceutical industry for analytical and quality control. She has 18 years’ experience working with many types of assay for all stages of drug development. She has been responsible for method development, method qualification, method validations, assay transfer, characterization work, and stability studies. Ms. Monsef has also worked with manufacturing groups to develop and perform assays to support their efforts. She has previously worked for Seattle Genetics and Alder Biopharmaceuticals and is currently consulting for Alder Biopharmaceuticals.

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