Jim Bergum received his Ph.D. in Statistics from Montana State University in 1981. He has worked in Non-Clinical Biostatistics since 1981 (Wyeth (To 1988) and Bristol Myers Squibb (present) providing statistical collaboration with Research & Development primarily in the areas of Chemistry, Manufacturing, and Controls (CMC). His areas of expertise include design/analysis of experiments, design/analysis of stability studies, sampling/statistically based criteria for process validation, Quality by Design (QbD) and “design space”, and product specifications. He developed and published methodology and a SAS program (CuDAL) to generate acceptance limits for process validation (ASTM E2709 and E2709 referenced in FDA process validation guidance). He has also developed alternative acceptance criteria for large sample sizes. Jim is a member of the ASA, ASTM, IQ, and a PQRI work group.