In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective.
It will cover how to get the attention of your senior management as well as practical advice on efficient methods for conducting and documenting management reviews.
Included will be best practices for planning, setting an agenda, notifying attendees, as well as what and how to document your management review, so you can prove to the FDA that an
Why should you Attend: Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your management. It is not only important to know what must be covered, but how to present this information to your management team. Learn how to get management’s attention to the information being presented and how to make it fit your company culture. Obtain practical information on conducting and documenting management reviews.
Areas Covered in the Session:
Understand the requirements of Management Review
How to get Senior Management Buy-In
Making Management Reviews effective
Making Management Review fit your company culture
Place in Risk management
Conduct a Management Review
Who Will Benefit:
Quality Systems Management Representatives
Senior managers of medical device companies
Medical device Consultants
Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.