In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Management requires suitable metrics presented in Management Review to understand, monitor, and improve the health of the Quality Management System. It is critical that management establishes a quality policy, quality objectives, and provides adequate resources. However, management often fails to realize the importance of their role with respect to quality. In this course, we will discuss how to improve awareness, focus, and a culture of quality. We will discuss how you can keep management aware and informed. We will discuss “red flags” or warning signs of problems.
Why Should You Attend:
Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus. Yet, they are frequently unaware of their responsibilities, leading to compliance issues, quality problems, and customer dissatisfaction. Management is unaware of gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight metrics to ensure your management is well informed on the health of the QMS, and provides the right level of oversight, attention, and resources.Areas Covered in the Webinar:
This 90-minute webinar will include:- Regulatory Expectations for Management Responsibility and Management Review
- Park Doctrine
- Lessons Learned
- Metrics to monitor the health of your QMS
- Effective Management Review
- How a culture of quality and compliance can encourage clear and transparent communication of risk.
- How to prioritize, resource, and implement improvements
- Tools for monitoring and communicating risk and improvement over time.
- How to identify residual risk.
- Signs that your company culture is taking unnecessary compliance or quality risk.
Who Will Benefit:
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Auditors
- Auditor Managers
- Supplier Auditors
- Training Specialists
- CAPA Specialists
- Quality/Compliance leaders, managers, or directors for Medical Device companies
- General Managers wanting to learn how to Management Review and expectations
Course Provider
Susanne Manz,
