Christopher (Chris) Kotevich, Managing Director and Quality Consultant of Crystalline Solutions provides GMP, ISO, Due Diligence and Production Efficiency support to Pharmaceutical, Highly Specialized and Technical Manufacturers. During the past 20 years, Chris has extensive executive level leadership experience in the operations and quality teams for; an international global speciality chemical manufacture, an international Tier 1 automotive subcomponent manufacturer as well as several leading solid oral dosage form manufacturers. As Director of Quality and Compliance for a major Pharmaceutical R&D and CMO company, he has conducted hundreds of internal, regulatory and customer compliance audits. As Managing Director of Crystalline Solutions, Chris' goal is to look behind the paperwork and report on the "real" quality compliance of a facility.
Regulatory compliant companies can still miss shipments, send substandard product and put your company at risk. A Crystalline Solutions audit report will highlight not only regulatory compliance but also production efficiency and finished product quality reliability.
Chris holds a B.Sc in biology and chemistry, is certified in GMP and ISO auditing, Lean Manufacturing, 5S Efficiency Modelling and is the inventor of the Human Calibration (patent pending) Quality Inspector Training method.
Chris is a recognized expert in Encapsulated Solid Oral Dosage forms and has consulted for the Canadian government and currently has unaccompanied visitor security clearance.