Mr.Erol Ali Cetinok

Erol Ali Cetinok has over twenty-five years of experience in various engineering, compliance, validation and quality roles. His educational background is in Mechanical Engineering and has extensive experience with quality management systems with respect to FDA/ISO standards and compliance in a regulatory environment. Erol has experience in the Life Sciences, Automotive, Telecommunications and other industries. He has filled many roles that have varied from validation protocol development and execution, product engineering, compliance consulting, quality system implementation, and quality system audits. This experience includes small and large companies operating in the US, Europe and Japan. 

Erol was at Indiana University Medical School for over 6.5 years.  During this time Erol served as the Quality Compliance Specialist for the Indiana University Vector Production Facility. This facility generates clinical gene therapy vector products for Phase I/II trials, and have published extensively on release testing to meet FDA requirements. Erol was responsible for two Drug Master Files with the US FDA related to vector production and certification. The site serves as the lentiviral production site for the NIH/NHLBI Gene Therapy Resources Program and has expertise in large-scale production and certification methods. Erol was also responsible as the site of the NIH National Gene Vector Biorepository and have a variety of state-of-the-art services and reagents for gene therapy.  In his role as the Quality Compliance Specialist, Erol was intimately involved with the implementation of novel production and certification methods.  Erol worked on a team that sought to meet the regulatory challenges in this developing field.

Erol also has experience with a wide variety of FDA regulated products such as medical devices, in vitro diagnostic reagents and instruments, in vivo diagnostics, pharmaceuticals, combination products, nuclear medicine, biologicals, and of course gene therapy. As an engineer, quality professional, and entrepreneur, Erol has developed a reputation for custom designing complete and seamless approaches to client challenges that incorporate both technical and business considerations.

He is a Certified Biomedical Auditor (CBA) and trained as ISO Lead Auditor. Erol’s BSME from Purdue is complemented by his Political Science degree from Indiana University helping him understand the regulatory process and language; his work toward an MBA provides business insight. He is a member of ASQ – American Society for Quality, ASQ Biomedical Division Midwest Discussion Group, ASGCT – American Society of Gene and Cell Therapy, AABM - Association of Academic Biologics Manufactures, ASME – American Society of Mechanical Engineers and SAE – Society of Automotive Engineers.