Brian Shoemaker

Brian Shoemaker, Ph.D., is Principal Consultant at ShoeBar Associates which focuses on services related to software application and development for companies in the FDA regulated area (medical devices and diagnostics, biotechnology, pharmaceutical, and vendors to any of these). 

  • He has more than 20 years’ experience with software quality and validation in the FDA-regulated industry.

  • He is knowledgeable in diverse application areas, including automated in vitro diagnostics, clinical trial data management, clinical safety data, ERP and shop floor automation, change order management, and electronic document management.

  • He is well versed in practical application of FDA and ISO requirements for software life cycle documentation, validation, and risk management. 

  • He is adept at unraveling issues around electronic records and signatures (21 CFR Part 11). 

  • He has diverse clientele, including manufacturers, software developers, medical device startups, and pharmaceutical multinationals.



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