Profile

MR Worlanyo Sosu-Sedzorme, RAC

Genomedx Biosciences

Contact Details

Genomedx Biosciences

Bio

Excellent knowledge of the clinical research process and regulatory guidelines including FDA, Health Canada, and ICH/GCP, guidelines.

Regulatory submissions to Health Canada, US Clinical Laboratory Improvement Amendment (Federal and State), College of American Pathologists (CAP); Regulatory inspections.

Implementation of Quality Management System (CLIA and 21 CFR 820) and Quality Assurance process, implementation and operation of Document Management System

Quality Management System for Software Development and Validation.

Job History

GenomeDx Biosciences Inc.
Regulatory Affairs& Quality Assurance Manager
March 2012 - present