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Biopharmaceutical Analytics: From Development to Validation
August 21-22, 2017
New Brunswick, NJ
Course Offering 170821NJ2729
Course ID 2729
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
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.
New Brunswick, NJ Area
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