Angela bazigos, ceo
Angela has degrees in Microbiology and Computing and 40 years of experience in the Drugs, Biologics, Medical Devices, Healthcare & Food. Experience combines GxPregulations in Quality Assurance, Regulatory Compliance, Clinical Trial Science, Information Technology, Data Integrity, Data Migration, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers/clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers, Veracyte, and other Medical Device Companies & Stanford Hospital. Consult to startups, investors, pharma, biotech, medical device, and food companies. Past Positions include Chief Compliance Officer, Director of QA, and MIS Director. Deep expertise in FDA CSA, Computerized Systems and IT Quality. Co-authored & prototyped 21 CFR 11 guidance with FDA and comments on GaMP5 and FDA guidance documents. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Quoted in the Wall Street Journal for using training to bring regulatory compliance to the Boardroom . Author of the recently published article "A guiding Light" in European Biopharmaceutical Review-journal https://en.calameo.com/read/006113385fcd8e422743a Comments / collaborates with FDA on new guidance documents. Vice President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for Life Sciences; Adjunct Professor at UC Berkeley.