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Biopharmaceutical Analytics: Regulations and Validations: Extended Online Course

  April 12, 2019  
CfPA-The Center for Professional Advancement, Online Live
July 10, 2019 at 8:30 a.m.–4:30 p.m. (ET)

Who Should Attend?
This course is designed to provide training to biopharmaceutical personnel on the analytical regulations involving method validations. Regulations and how they pertain to analytics, method qualification and validation and method trending will all be course topics. Personnel with experience or just getting started will both benefit from this course. This course is recommended for Quality Control, Quality Assurance, Analytical Scientist, Research Associates, Product Development and Manufacturing departments.

Course Description
This extended online accredited training will teach basic analytical regulations as they apply to method validations. This course will go through multiple bioanalytical methods and how to examine them for validation readiness and how to perform a validation. The methods in this course will include UV-VIS, SE-HPLC, HIC HPLC, Affinity HPLC, SDS-PAGE, IEF Gels, CE-SDS, cIEF and ELISA.


Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Rachel Monsef, Consultant to the biopharmaceutical and pharmaceutical 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. She has been responsible for method development, method qualification, method validation, assay transfers, characterization work and stability studies. Ms. Monsef 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 both companies.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: Jmorbit@cfpa.com
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