Thursday, November 24, 2011

Common Audit Problems and How to Deal with Them

by
Richard A. Vincins is a Certified Quality Auditor and regulatory affairs consultant with Emergo Group. He is responsible for the implementation of quality systems, conducting internal audits, training on quality system tools, and providing regulatory expertise in national and international regulations. Vincins has more than 19 years of experience in the medical device industry, including worldwide regulatory compliance efforts for in vitro device, medical device, and pharmaceutical companies.

We often perform audits and wonder why, when they’re complete, they didn’t go very well. This article will offer insight on how to better anticipate and solve the common problems that all auditors face. This is going to take some personal work on the readers’ part. My hope is that after reading this article, you can apply these insights to your auditing practices to make you a better auditor and ultimately get more out of the audit process.

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