2-day In-person Seminar on “Quality Audits for the Medical Device Industry” 2014

Summary of the workshop:

Quality audits are an important element in checking the health of a Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.
When you read an FDA Warning Letter do you ask, "Where was the internal audit program?" Why didn't the company find it themselves?
In this seminar participants will look at the various kinds of audits and understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program. Don't forget that you could be the supplier being audited. Independent audits (3rd party) can help provide assurance about the health of a QMS.

Learning Objectives:

This seminar will help you create an effective quality audit program for medical device manufacturing. Your audit program needs two major elements. First, you need a plan to schedule, conduct, report, and close audits. Second, you need qualified people to perform the audits. The seminar explains how to implement the quality audit program elements using examples and exercises that help develop the necessary skills.
Another important part of an audit program is responding to audit non-conformances. This includes correction, investigation, and corrective action. An effective audit program will determine and eliminate the cause of the nonconformity. These methods are important in all three audits types. The seminar provides methods and exercises to help implement these important activities.
Management needs to understand the results from each audit type, which are presented at Management Review. The presentation should use statistical methodology to analyse quality audit reports. The seminar discusses the role of management review and helps you identify the appropriate statistical methodology.

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