Good Manufacturing Practices are regulations to ensure proper design, monitoring, and control of manufacturing processes and facilities.
These processes involve strict adherence and compliance with regulatory requirements and quality management systems. Audits are routinely used to confirm compliance and to provide feedback to manufactures on the success of their quality management systems. In this course, participants will gain an understanding of the different types of audits performed on medical device manufacturers, key approaches to audits, the roles of auditors and auditees, and how to best prepare for audits conducted by regulatory agencies.
Participants in this course will learn:
• the different types of audits
• key approaches to audits
• the roles of auditors and auditees
• best practices
This course is available online, and can be taken anytime, anywhere.