Albert Cefalo
Instructor Albert Cefalo
Product Id 600125
Duration 60 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Management Review: The Complete Requirements


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

Speaker Profile
Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University. For the last 21 years he has been employed by Analogic Corporation. During his career at Analogic he has involved in all activities related to Quality Assurance and Regulatory Affairs such as Creation and maintenance of SOPs, FDA, Health Canada and CCC submissions as well as served as Director of quality for several of Analogic's Business Units. Chuck also conducts in-house training on a variety of subjects. Chuck is the Regulatory Affairs representative on all of the Analogic Project Teams and provides an oversight of the Risk Management process.

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