GxP Lifeline
Weighing FDA's Response to the COVID-19 Pandemic
The U.S. Food and Drug Administration (FDA) partnered with other agencies, created the Coronavirus Treatment Acceleration Program (CTAP) and used every available procedural tool, including the Emergency Use Authorization (EUA), to aggressively respond to the realities of COVID-19. Understand the impact of these actions and what they mean for the future. Read the full article written by Coda Corp USA.
Gina Guido-Redden is a quality and regulatory professional with over 25 years of domestic and international industry experience. She is the co-founder and chief operations officer of Coda Corp USA, which provides consultancy services to pharmaceutical, biologics and medical device firms.
Guido-Redden’s history specializes in the areas of facility start up, regulatory compliance and remediation, quality system development, mentorship and training, quality system design, and implementation and management.
She is also a quality systems subject matter expert (SME), frequent seminar presenter, and content contributor to industry publications, including GAMP’s White Paper on Part 11, The Journal of Validation Technology, New Generation Pharmaceuticals, Computer Validation Digest, and MasterControl’s GxP Lifeline. Coda Corp USA is an enterprise partner of MasterControl.
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