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FDAnews Device Daily Bulletin

Cooperation, Not Confrontation, Key to Internal Audits

March 10, 2017

The most common error companies make when conducting internal audits is to take a confrontational approach when fixing them, according to one compliance expert.

Internal audits should be used as a learning tool and teaching mechanism, advised Susan Schniepp of Regulatory Compliance Associates, in a webinar hosted by FDAnews. “Remember that the goal is to find any deficiencies before the government does and fix them,” she said.

Internal audit programs should focus on several elements, including communication, objectives, documents, interviews, scope, follow-up, procedures, and management. It is important for internal audits to be team-oriented, instructive, informative, honest, and forward-thinking. They also should be announced in advanced so the people involved have time to prepare.

Order materials from the Feb. 28 webinar here: www.fdanews.com/products/49994.

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