Daniel O'Leary - President, Ombu Enterprises, LLC
Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.
In this workshop, participants review the various kinds of audits to 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; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS.This workshop provides the tools to establish and maintain an effective quality audit program for medical device manufacturing. This includes the two major elements. First, is a plan to schedule, conduct, report, and close audits. Second, is the assignment of qualified people based on skill and considerations of conflict of interest. The workshop explains how to implement these 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 nonconformances. This includes correction, investigation, and corrective action. An effective audit program determines and eliminates the causes and contributors to the nonconformity. These methods are important in all three audits types. The workshop provides methods and exercises for these important activities.Management needs to understand the results from each audit type as part of Management Review. The presentation should use statistical methodology to analyze quality audit reports. The workshop discusses the role of management review and helps identify the appropriate statistical methodology.
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Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.
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The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.