Darshana Patel Merck & Co., Inc.

Darshana Patel is an Associate Director who works at Merck & Co., Inc in Global Quality Compliance Support group. For the past 18 years, she has worked in various Technology and Quality roles to support the mission of providing best in class products to patients. Her expertise includes Equipment Validation, Technology Transfer, Process Validation, Quality Risk Management, Deviation Management, Change Controls, Quality Systems. Her current responsibilities incude providing support to sterile and Low Bioburden manufacturing facilities as well as CMOs to address any compliance and quality risks. She also is responsible for the global QMS documents related to sterile and low bioburden manufacturing. Darshana is passionate about Quality Risk Management (QRM). Through her engagement, collaboration, proactive support and standardization of practices, she wants to influence industry leaders and regulators. Darshana has been recognized in her field for presenting at KENX conference about Quality Risk Management and co-published a paper on 'Navigating the Formality Spectrum in ICHQ9 (R1)' in Pharmaceutical Technology and Pharmaceutical Technology Europe. She graduated from New Jersey Institute of Technology in Biomedical Engineering.