Attend this course to gain a fundamental understanding of successful bioanalytical assay development and validation. This course is composed of primarily hands-on activities with some lecture. You’ll get hands-on experience with designing and developing assays, then validating them by considering ICH guideline Q2(R1). You’ll gain an appreciation for the complexities involved in biopharmaceutical analysis and learn about troubleshooting, data analysis, and experimental design. You’ll also gain a fundamental understanding of analytical technologies used in biomanufacturing QC/analytical laboratories and get hands-on experience with spectroscopy, electrophoresis (gel and capillary), U/HPLC, MALDI-TOF mass spectrometry, and ESI liquid chromatography-mass spectrometry. In addition, you’ll gain an appreciation for the various tools available for biopharmaceutical analysis.