Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 healthcare firms in a wide range of validation, aseptic processing, sterilization, and compliance areas. Jim has over 45 years of industry experience. He has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, and validation during his career at Merck, Pfizer, Squibb and Bristol-Myers Squibb. Jim is a past President and Director of PDA. He is a member of USP’s Microbiology Expert Committee for 2005-2020. He has authored or co-authored more than 40 book chapters, over 110 papers and lectured extensively on sterilization, aseptic processing and process validation for PDA, ISPE, PhRMA, and other organizations, domestically and internationally. He is co-editor of Validation of Pharmaceutical Processes and Advanced Aseptic Processing Technology.