Vice President of Consulting Services, Azzur Group
As a quality assurance consultant with over twenty-five years’ experience in the Pharmaceutical, Biologic, Medical Devices, In-Vitro Diagnostic (IVD) and combination product industry, Cinta Burgos ensures that client products are safe and that they are effective. Cinta is an accomplished GMP, GLP, and GCP quality professional with in-depth knowledge of FDA, EU and rest of world regulations, with several successful product launches. Cinta has worked in various positions in research engineering, validation engineering, and quality assurance and in large global companies as well as small start-ups. As Azzur Group Vice President of Consulting Services she is responsible for the QA/RA Compliance of Technical Projects. Prior to entering the life science industry, Cinta was a microbiology laboratory researcher. Cinta has a BS in Biophysics from UC San Diego, has completed graduate student level work in Mechanical Engineering, was an adjunct faculty member of Tuft Veterinary School teaching a masters level course in Good Laboratory Practice, is currently on the Board of Directors of ASQ Medical Device Division, an active member of Society of Women Engineers, and an ASQ recognized Medical Device expert as an author of the ASQ Book of Knowledge EU Medical Device Regulation 2020 updates. Cinta’s expertise includes Quality Management Systems; Product Development including QTPP, CQAs, and Design Controls; Deviations, CAPAs and Complaints; Risk Management; Batch Record Review; Supplier Management and GLP, GCP, and cGMP Audits.