In this course, you will gain a fundamental understanding of successful bioanalytical assay development and validation and the complexities involved in biopharmaceutical analysis. You will 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. You will also learn about troubleshooting, data analysis, and experimental design. This course is appropriate for 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 expand their knowledge will also find this course beneficial.

Instructor: Nathaniel Hentz, Ph.D.

Registration: 

Employees of BMF companies or groups of five or more from one company are entitled to a 20% discount. Faculty/staff working in academic environments are eligible for a 50% discount.

To register please visit go.ncsu.edu/btec_short_courses.