Transcription of Creating an Efficient Internal Audit Program
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Creating an Efficient Internal Audit Program
Creating an Efficient Internal Audit Program Carol CekalaSusan ReillyTDC MedicalReilly & AssociatesPresentation topics What is an Audit ? Making it work Who audits? Selling to management Communicating resultsWhat is a quality Audit ?What is a quality Audit ? Objective assessment, performed at defined intervals and at sufficient frequency, of a company s quality system to operate against a given criteria{Systematic{Independent{Document edWhat is a quality Audit ? Provide factual, unfiltered information to manage the quality system A tool for use by management Regulatory requirement (FDA, ISO, etc.) Help minimize risk Close the loop for other elements of the quality systemWhat is a quality Audit ? Detect Program defects and through isolation of unsatisfactory trends and correction of factors that cause defective products, prevent the production of unsafe or nonconforming devices.}}}
Presentation topics What is an audit? Making it work Who audits? Selling to management Communicating results
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