About ShoeBar Associates
Principal Consultant: Brian Shoemaker, Ph.D.
- More than 20 years’ experience with software quality and validation in the FDA-regulated industry.
- 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.
- Well versed in practical application of FDA and ISO requirements for software life cycle documentation, validation, and risk management.
- Adept at unraveling issues around electronic records and signatures
(21 CFR Part 11). - Diverse clientele, including manufacturers, software developers, medical device startups, and pharmaceutical multinationals.
Speaker Profile
Brian Shoemaker has given numerous presentations, on a diverse array of topics related to software development quality, software quality systems, software risk management, software standards, and Agile methods for regulated medical software.