In today's dynamic business environment, every aspect of an organization needs to perform value-added activities that have a positive impact on the bottom line. Regulatory and quality units in more and more biomedical industry corporations are relying on quality audits as a means to improve operations. By auditing domestic and international quality system regulations (GXP, QSR and ISO), these organizations are assessing and improving the effectiveness of their internal systems and those of their suppliers and corporate partners.

This hands-on course introduces participants to fundamental auditing principles and techniques including planning, conducting, analyzing, and communicating audit results in terms that are meaningful to senior managers. By understanding the psychology of audits and practicing questioning techniques, participants will take their organization's quality audit program to another level.

Learning Outcomes

At the conclusion of the course, you should be able to

• Explain how audits can help an organization achieve its strategic business objectives
• Provide a brief overview of the audit process
• Understand the psychology of audits
• Learn different ways of using questioning techniques to make the audits “value added”
• Understand, communicate and present non-conformances to 21 CFR 820 in a simulated audit setting
• Understand the MDSAP audit model

Topics Include

• Anatomy of the Audit Process
• Attributes of a Good Auditor
• Auditor Strategies
• The Communication Process

Necessary Knowledge

• To be successful in this class all students should have working knowledge of Google Workspace or Microsoft Office, proper email etiquette, and an essential understanding of Canvas.
• MEDD.X407 " Quality Systems for Medical Devices: ISO 13485 and FDA Requirements" or equivalent experience.

Additional Information

Most of the class materials provided via Canvas