Auditing is a reality in the world of medical devices. It has many facets, including, but not limited to, first-party, internal, second-party, supplier, external, US Food and Drug Administration (FDA), ISO, etc. Regardless of the audit’s nature and scope, the outcomes are basically the same. Typical audit outcomes involve some sort of action to come into compliance with standards or regulations and make improvements to quality management systems.
Compliance and improvements may be in the form of corrective and or preventive actions, as well as corrections. Audits may identify areas that need improvement and offer valuable insight into the proper functioning of a compliant Quality System.
This course will provide the fundamental good quality auditing practice knowledge and skills. It is intended to review the background on auditing practice and the evolution of the requirements from a regulatory point of view and provide an overview of the applicable regulations.
Learning Objectives
Upon completion of this course, participants will be able to:
- Prepare and conduct an audit and audit close-out meeting.
- Develop the records required to document audit activities.
- Describe auditing techniques, useful tips and methods employed by skilled auditors to get at underlying issues or to assure compliance.
Target Audience
This course is designed for quality and regulatory professionals with little or no previous auditing experience and individuals who need to broaden their knowledge.