CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
March 30-31, 2020
Who Should Attend?
In analytical method development, issues can arise with method specificity, robustness, accuracy and precision. Being able to develop a method suitable for a regulatory environment is key to success in biopharmaceutical analytics. This course will teach which how to develop, trend, improve and trouble shoot analytical methods for biopharmaceuticals. 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:
• Research and quality personnel wishing to deepen their knowledge on the mechanism of methods and their reportable data
• Research and quality personnel developing analytical methods for biomolecules
• Research and quality personnel working to make methods more robust and preparing for regulatory environments
• Discovery and formulations personnel developing platform and first line methods for new products Course Description
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Invited Speakers:
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 Rachel Monsef, Consultant to the pharmaceutical and biopharmaceutical industries |
Rachel Monsef is a consultant to the biopharmaceutical and pharmaceutical industry for analytical and quality control. She has 19 years’ experience working with many types of assays for all stages of drug development. Ms. Monsef has been responsible for method development, method qualification, method validation, assay transfers, characterization work and stability studies. She has been involved in method trouble shooting and assisting with “troubled” validations. Ms. Monsef has worked extensively with coordinating method development and validation work performed at CMO’s as well as trouble shooting methods that do not have the robustness needed for regulatory compliance. She has previously worked for Seattle Genetics and Alder Biopharmaceuticals and is currently consulting for both companies.
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Maximize Your Learning!
Attend this course and its Companion Course:
Biopharmaceutical Analytics: Regulations and Validations
April 1–2, 2020 • Edison, NJ • Course ID #2780