Formedix
Katrina M. is a seasoned quality assurance professional with extensive experience in the pharmaceutical and biotechnology sectors. Currently serving as the Quality Assurance Manager at Formedix since September 2022, Katrina manages the quality management system, ensures compliance with industry regulations, and facilitates internal audits. Previously, Katrina held various roles at IPSEN BIOPHARM LIMITED, including Senior GxP Quality Audit Manager, where oversight of GxP audit planning and quality expertise were key responsibilities. Additional experience includes positions at GlaxoSmithKline, Allergy Therapeutics (UK) Limited, Thermo Fisher Scientific, and Novartis, encompassing roles in internal auditing, quality assurance leadership, and project management. Katrina holds a Bachelor of Science degree in Chemistry from Anglia Polytechnic University, Cambridge.
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Formedix
Want to get your clinical trials designed, built & submitted, faster? Now you can, with our off-the-shelf clinical metadata repository and study automation platform. We’ve automated those time-consuming and expensive manual tasks, from study set up to submission. Our clinical metadata repository (MDR) provides a central home for your organizational standards. Here you can manage and update your standards – whilst keeping on track with CDISC standards, and complying with regulatory requirements. You can even share content across different EDC and e-clinical systems. And if you need help with study automation, we can do that too. Our study automation tools use the content in your metadata repository to help design and build your studies much faster. Whether you want to build EDCs, create define files, annotate CRFs, convert datasets, or validate your study… Formedix makes it quick and painless.