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Biopharmaceutical Analytics: Regulations and Validations

  November 14, 2019  
CfPA-The Center for Professional Advancement, Edison, NJ or Virtually
April 1-2, 2020

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 started will both benefit from this course. This course is recommended for Quality Control, Quality Assurance, Analytical Scientist, Research Associates, Product Development, Manufacturing, and Validation. Of course, anyone in the industry wishing to expand their knowledge in Biopharmaceutical analytics are encouraged to join.

Course Description

This 2-day accredited training was designed to give an in depth understanding of method validations and analytical regulations. The course begins 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 this is established, this course will answer questions as to which parameters need to be tested for each type of method validation, as well as the experiment design for these validations. This will be done by examining each type of method, the experiments needed, and what to do if exceptions are needed.

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.

Maximize Your Learning!
Attend this course and its Companion Course:
Biopharmaceutical Analytics: Method Development
March 30–31, 2020 • Edison, NJ • Course ID #2779
Organized by: CfPA-The Center for Professional Advancement
Invited Speakers:
   Rachel Monsef, Consultant to the pharmaceutical and biopharmaceutical 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. Ms. Monsef has been responsible for method development, method qualification, method validation, assay transfers, characterization work and stability studies. She has been involved in method trouble shooting and assisting with “troubled” validations. Ms. Monsef has worked extensively with coordinating method development and validation work performed at CMO’s as well as trouble shooting methods that do not have the robustness needed for regulatory compliance. 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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