Assay Development and Validation for Biomolecules

July 24-25, 2012

 

Why Should You Attend

Gain a fundamental understanding of successful bioanalytical assay development and validation. Get hands-on experience with designing and developing an ELISA. After assay optimization, the ELISA will be validated by considering ICH guideline Q2(R1) and FDA Guidance: Bioanalytical Method Validation. Gain an appreciation for the complexities involved in biopharmaceutical analysis. Learn about troubleshooting, data analysis and experimental design. This course is composed of primarily hands-on activities with some lecture.

Attend and You Will Learn

  • In-depth operation of ELISA
  • How to design, develop, optimize and validate an ELISA
  • How to work with nonlinear data
  • Critical sources of variability in ELISAs
  • Bioanalytical method development and validation

Who Should Attend

  • Professionals new to the biopharmaceutical industry or entering new work assignments encompassing analytical or QC environments.
  • Professionals with previous QC/analytical experience who want to learn new techniques and/or broaden their understanding.

Attend and You Will Receive

  • 1.4 CEUs
  • Morning coffee
  • Lunch
  • Afternoon beverage break
  • Certificate of attendance

Instructor

Nathaniel Hentz, Ph.D.  

Cost

$1150 (20% discount available to employees of BMF companies and those companies with 5 or more attendees; 50% for academic affiliated faculty/staff); special discount for members of the Society for Industrial Microbiology and Biotechnology (SIMB).