Presenter : Susanne Manz
This 90 minute Webinar will cover the concepts of measurement, analysis, and improvement to ensure conformity of products, conformity of the management system, and on-going effectiveness.
This webinar includes strategies to improve the efficiency of your Quality Management System (QMS) for medical device companies. An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality.
This webinar will get you started in setting up just such a Quality System. We’ll discuss techniques for improving efficiency, reducing burden, and still maintain an effective QMS.
In this webinar, we will discuss:
– Regulatory Expectations
– Common problems and lessons from 483 and warning letters
– Red-flags that your QS is not effective
– Measurement and metrics
– Feedback, Complaint Handling, Internal Audit
– Analysis of data
– Risk based thinking
– Improvement and your CAPA process
– Management Review
Why You Should Attend:
This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of ineffectiveness and inefficiency in your QMS.
This webinar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters!
The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices.
Areas Covered in the Session :
Who Should Attend: