Course Description

Biopharmaceutical Analytics: From Development to Validation

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

Course ID 2729

In-Person Course

Who Should Attend?
This course is designed to provide training to biopharmaceutical personnel on the purpose and functions of an analytical program, strategies for analytical testing (from developing a method through validation), select characterization methods, and quality systems essential for an analytical group. This course is recommended for:

  • Quality Control, Quality Assurance
  • Analytical Scientist
  • Research Associates
  • Engineers and Administrators working in analytical development, Product
     Development, Manufacturing, Validation, Formulation, and Pre-formulation
     groups, though any inquiring minds within this industry are welcome to join

Free Introductory Webinar Available: Preview it Now

To register for the free webinar, click the link below

Course Description
This intensive, 2-day course will take participants on a journey showing the different functions and responsibilities required by an analytical group through all the stages of drug development. It will begin with understanding regulations to build a foundation of how a compliant lab and strong methods should be built, then will continue through the evolution of the test methods and functionality of an analytical group through the method validation stage. Throughout this journey different strategies for developing, assessing, qualifying and validating test methods to meet ICH guidelines will be examined. Select characterization methods, new technologies and how they fit into an analytical program will also be evaluated. 

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

Rachel Monsef is an analytical chemist in the pharmaceutical industry who has 16 years’ experience working with many types of assays for all stages of drug development. She has worked on several projects that required method development all the way through method validations. She has experience with assay transfer, characterization work, and stability studies. She has also worked with manufacturing groups to develop and perform assays to support their efforts. She has previously worked for Seattle Genetics, Nastech and has had many different roles at Alder Biopharmaceuticals where she is currently acting as a quality control consultant.

Ms. Monsef received her Bachelor of Science in Chemistry from the University of Washington.

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