Former Vice President, Quality Assurance, Tempus Labs Joins NDA Partners as Expert Consultant

ROCHELLE, Va., Jan. 5, 2022 /PRNewswire-PRWeb/ -- NDA Partners Vice President of Operations, Eric Fish, announced today that Taranjit Samra, DRSc, MSEE, a quality assurance and regulatory compliance executive, has joined NDA Partners as an Expert Consultant.

Dr. Samra has experience across medical device, diagnostic, clinical lab, software, and high-tech and biotechnology industries, including extensive experience in global quality system implementation (including eQMS) for FDA QSR, ISO 13485, GxPs and CLIA/CAP, and hands-on experience in all aspects of quality assurance such as design assurance, software development lifecycle (SDLC), manufacturing operations quality, supplier quality, CAPAs, complaints, and training. He is a certified Lead Auditor and has performed GMP audits, QMS gap assessments, mock audits and led inspection readiness for FDA, notified body/EU, Medical Device Single Audit Program (MDSAP), and regulatory agency audits from Japan, China/SFDA, and Brazil. He has also influenced the regulatory landscape as a lead pilot participant for the FDA Digital Health Software Precertification program in addition to developing regulatory strategies and best practices for SaMD, cybersecurity, AI/ML, bioinformatics, and data and cloud technologies, including computer system validation (CSV)/Part 11.

Prior to joining NDA Partners, Dr. Samra served in Vice President/Head of Quality Assurance and Regulatory Compliance positions at Tempus Labs, Guardant Health, Grail, and Verily (Google) Life Sciences. He was also Director of Quality Assurance at Illumina and Sr. Manager of Global Quality at Varian Medical Systems (Siemens Healthineers).

According to Ms. Roberta Sanchez, Manager of NDA Partners' Quality Management Systems and Quality Systems Regulation practice, "Dr. Samra's extensive experience in quality assurance and regulatory compliance will be valuable to our clients in the medical device, diagnostic, clinical lab, and software product areas."

Dr. Samra received his Doctor of Regulatory Science from the University of Southern California, Master of Science in Electrical Engineering from Simon Fraser University in British Columbia, Canada, and Bachelor of Science in Electrical Engineering from Thapar Institute of Engineering Tech in India. He has authored books on medical device software, and global regulatory strategy published through the Regulatory Affairs Professionals Society (RAPS).

About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.

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Eric Fish, Vice President, Operations
Office: 540-738-2550
[email protected]

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Eric Fish, NDA Partners, 540-738-2550, [email protected]

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