Course Description

Biopharmaceutical Analytics: Regulations and Validations

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

Course ID 2780

In-Person Course

Who Should Attend?
This course is designed to provide training to biopharmaceutical personnel on the analytical regulations and method validation. Regulations and how they pertain to analytics, method qualification and validation, method transfers and method trending are all major course topics. Personnel with experience or just getting starting will both benefit from this course. This course is recommended for Quality Control, Quality Assurance, Analytical Scientist, Research Associates, Product Development, Manufacturing, Validation, though any inquiring minds within this industry are welcome to join.

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Course Description
This 2-day accredited training will begin with teaching basic regulations to build a foundation of how a compliant lab and strong systems should be built. The course will then examine methods and attributes that need to be in place prior to qualification and validation activities. Once the stage is set, method qualification and validation will be the main topic of the course. Additional topics will also be discussed such as transferring methods, what validation work needs to be done on compendial methods, how to perform a proper lab investigation, when a method needs to be revalidation or qualified, method trending, and FDA reviews.

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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