90-887 Washington Insider
6 units, Carnegie Mellon University
Todays working environment requires practical handson experience and knowledge about the regulations and standards that govern our businesses. Management needs to know the status of the organization in order to assess the overall risk of the corporation. This course provides information about and compares and contrasts various industry regulations and standards i.e. FDA Quality System Regulations FDA GMPs for Drugs ISO 9001 etc. in order to understand compliance approaches. The course will also provide fundamental information on the auditing process a valuable tool for management in assessing risk of an organization. The auditing process will be discussed in detail the basic terms and concepts of quality and system audit approaches and related terms. The psychology of auditing requirements of auditing personnel and methods of thoroughly and effectively performing an audit and communicating the results to both the audited and management will be discussed. The course will cover operational systems audits audit process analysis effective audit questioning and investigative techniques effective corrective action and utilizing audit program data to aid in achieving continual improvement. Discussion topics include How audits are used to assess organizational effectiveness system efficiency process effectiveness business performance risk management and conformance to requirements. Professional conduct and responsibilities with respect to confidentiality conflict of interest and discovery of illegal activities or unsafe conditions are also discussed. Workshops provide handson practical experience of the concepts presented during the course. The American Society for Quality ASQ Certified Quality Auditor Body of Knowledge CQA BoK and the ISO 9001200a hrefhttpwww.heinz.cmu.eduacademicresourcescourseresultscoursedetailsindex.aspxcid156...Read Morea
Prerequisites: none listed
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