Biopharmaceutical Analytics: From Development to Validation

September 09, 2016

CfPA-The Center for Professional Advancement, New Brunswick, NJ
January 25-26, 2017

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

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.

Organized by:

CfPA-The Center for Professional Advancement

Invited Speakers:

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.

Deadline for Abstracts:

n/a

Registration:

Please click here for registration information.

E-mail:

jmorbit@cfpa.com

home

genetic news

bioinformatics

biotechnology

literature

journals

ethics

positions

events

sitemap