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.
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.
Areas Covered in the Session:
Understand the requirements of Management Review
How to get Senior Management Buy-In
Making Management Reviews effective
Who Will Benefit:
Quality Systems Management Representatives
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.