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GxP Lifeline

Risk Management: A Primer for Lean Quality Assurance

Nobody wants to handle a crisis, which is why quality professionals are choosing to be proactive about managing risk. Through risk management, you reduce customer risk while ensuring the quality of your product. Understand the steps you need to take to be effective with risk management, and learn why it’s more than a means to being compliant – it’s a powerful tool. 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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