Loganathan Kumarasamy
Steering GxP Data, Digital Informatics and AI for Compliance
- Role
- Global Head - Compliance Services at Zifo
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Loganathan Kumarasamy
Thought Leader in Digital Transformation | Championing GxP Compliance through Innovative Digital SolutionsPassionate about bridging the gap between Digital Informatics and regulatory frameworks within the pharmaceutical, biotech, and medical device industries.Focused on harnessing the power of Artificial Intelligence and Machine Learning to enable engineers to deliver compliant, cutting-edge solutions.Open to discussions on Data Lakes, AI/ML, Digital Automation, Blockchain, and the future of digital innovation in regulated environments.
Experience
Global Head - Compliance Services
Apr 2025 — Present · Raleigh-Durham-Chapel Hill, NC, US
Education
Northeastern University
Master of Science (M.S.), Regulatory Affairs for Drugs, Biologics, and Medical Devices
2016 — 2017
Sri Sankara Vidyashramam
Higher Secondary, Biology, General
2004 — 2006
Anna University Chennai
Bachelor of Engineering (B.E.), Biomedical/Medical Engineering
2006 — 2010
Skills
- 21 Cfr Part 11
- Requirements Analysis
- Validation
- Computer System Validation
- Cdisc
- Medical Devices
- Gcp
- Premarket Approval (Pma)
- Regulatory Requirements
- Regulatory Affairs
- Lifesciences
- Hipaa
- U.s. Title 21 Cfr Part 11 Regulation
- Clinical Data Management
- Instrument Validation
- Quality Assurance
- Electronic Data Capture (Edc)
- Good Clinical Practice (Gcp)
- Sdlc
- Edc
- Life Sciences
- Fda Gmp
- Good Laboratory Practice (Glp)
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