Robert (Bob) R. Reich

Bob Reich is a working president; he has been instrumental in maintaining old as well as fostering new business relationships and growing LexaMed (Toledo, OH) not only in number of employees, but also in valuable expansion in laboratory and consulting services. Mr. Reich is a microbiologist with more than 35 years of experience in the healthcare industry in the areas of management, validation, quality, and regulatory affairs. He has extensive experience in pharmaceuticals including, but not limited to, aseptic processing, antineoplastic products, terminal sterilization of ampoules and vials, establishment environmental monitoring programs for both sterile and nonsterile dosage forms, OOS/CAPA investigations, CGMP and technical training, equipment and process validations, including isolators, ovens, depyrogenation tunnels, and washers. His medical device experience includes contract sterilization, contract laboratory services, packaging, biological indicators, medical device manufacturing, environmental control and microbiologically related quality control, R&D OOS/OOL investigations, regulatory submissions, and coordination regulatory inspections. He has been cochair of HIMA (now AdvaMed) technical committees on packaging validation and sterilization monograph review, as well as a member of task groups drafting guidelines on biological and chemical indicators, bioburden quantitation, and microbiological methods for the assessment of packaging integrity. He has served as cochair of ANSI/AAMI Industrial EO committees as well as a member of ISO/ANSI/AAMI technical standards committees on biological indicators, product EtO residuals, alternative chemical sterilants, packaging, microbiological methods, and aseptic filling. He has served as a member of the PDA task force, drafting guidelines on the validation of dry sterilization and depyrogenation processes. He has been a member of MD&DI's Editorial Advisory Board since 1984.