Here’s my CMC lecture for the 2023 University of Washington Biomedical Regulatory Affairs Masters Degree graduating class. In it, she explains how companies that produce drugs, biologics, and medical devices develop, validate, and operate processes that ensure the safety, efficacy, and quality of their products.
Being Strategic About Lab Investments
LinkedIn recently asked me to answer the question, “How can you use cost-benefit analysis (CBA) to make informed lab investments?” Their AI explained the basic steps for performing a CBA. However, there was zero context for strategically thinking about a lab...