Course Description

Biopharmaceutical Analytics: Method Development

March 6-7, 2018
New Brunswick, NJ

Course Offering 180306NJ2779
Course ID 2779

In-Person Course

Who Should Attend?
This course is designed to provide training to biopharmaceutical personnel on analytical method development on an array of different method types commonly used in the Biopharmaceutical Industry. For each method, participants will learn the mechanism of how it works, the reportable data, development techniques, how to trouble shoot and make a method more robust. This course will benefit personnel with experience wishing to deepen their knowledge in method development, or for personnel who are just getting started in analytics. This course is recommended for Quality Control, Analytical Scientist, Research Associates, Product Development, Formulation, and Pre-formulation groups, though any inquiring minds within this industry are welcome to join.

FREE Introductory Webinars Available - Register Now!

Course Description
This intensive, 2-day course will teach participants how to develop an array of different analytical methods used in the Biopharmaceutical Industry. Troubleshooting issues during and after development will be discussed for each method as well as practical approaches to strengthening the methods robustness. This accredited course also includes information on how the methods should be used to support manufacturing, regulatory filings and stability programs.

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 17 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. She 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.

Venue Information
The Heldrich Hotel
10 Livingston Avenue
New Brunswick , NJ 08901 US
Phone: 732-729-4670
Fax: 732-729-4672
Website: The Heldrich Hotel

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.