Medical Device Testing - Emerging Trends and Regulatory Expectations
What are the challenges we all face with Medical Device Testing? What new tests are coming down the pipeline? Get up to speed on all of the regulatory changes in Medical Device Testing at the FMMC's November Executive Briefing!
About Our Speaker: Robert (Bob) Reich - President - Lexamed
Robert Reich is a microbiologist with over 40 years of experience in the healthcare industry in the areas of Management, Validation, Quality and Regulatory Affairs. Extensive experience in both pharmaceuticals and medical devices. Pharmaceutical experience in aseptic processing, anti-neoplastic products, terminal sterilization of ampoules and vials, establishment environmental monitoring programs for both sterile and non-sterile dosage forms, OOS/CAPA investigations, cGMP and technical training, equipment and process validations including isolators, ovens depyrogenation tunnels, washers, etc. Medical device experience in 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 co-chair of HIMA 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 a co-chair of ANSI/AAMI Industrial EO committee as well as a member of ISO/ANSI/AAMI technical standards committee on Biological Indicators, product EO 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.
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