Shital PatelChief Operating Officer
Shital Patel is the co-founder and Chief Operating Officer (COO) of CRx Life Sciences. Shital has more than 12 years of consulting experience, and 18 years of project management, engineering, validation and compliance expertise in the pharmaceutical and medical devices industries, spanning both start-ups and Fortune 500 corporations.
She has held positions of increasing responsibility by leading risk reduction efforts within manufacturing environments by ensuring conformance to established control mechanisms for quality systems excellence in the areas of Validation, CAPA, Risk Management, and Design Control. Shital is a subject matter expert in ISO13485, ISO14971, ISO9001, MDD 93/42/EEC, FDA21CFR Part 820, FDA21CFR Part 11 and other standards (domestic and international) relevant to the medical devices and pharmaceutical sectors.
Shital received her Bachelor of Science degree in BioEngineering from the University of Illinois.