One of the main elements to a fully implemented Quality Management System (QMS) is the Management Review.
Whether you are in the medical device industry or a non-medical industry, Management Review is a required element of your QMS. This webinar will provide the attendee with a concise definition of what a Management Review entails and what is asked for when an audit or investigation is performed of your organization. Even though there are regulations regarding the accessibility of management review contents to third party investigators, this does not mean that a complete and concise review should not be performed. Executive management will greatly benefit from this webinar as it will provide them with the information to conduct and document a Management Review. Each element that should be contained within the review will be discussed along with a description of the source of the review content. A Management Review should not just be an exercise to take a snapshot in time regarding the health of an organizations QMS, but it must be a process whereby definitive goals are set for accomplishment between the review periods. In addition to the topics listed above, a method for documenting a Management Review for provisions in a system where the investigator is not privy to its contents will be discussed and defined.
Areas Covered in the Session:
- QMS Requirements for a Management Review
- Components of a Management Review
- Documenting a Management Review
- Providing FDA Evidence of a Management Review
Who Will Benefit:
- Executive Managers
- Program Managers
- Quality System Managers