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Validity : 12th Sep'21 to 22nd Sep'21
This 90-minute webinar will include:
Many medical device companies are surprised when they have a recall, a 483, or even a warning letter. To prevent these quality and compliance issues, a company needs to have an efficient and effective Quality Management System (QMS) including good metrics and dashboards. Metrics and dashboards can help to proactively and consistently measure the health of the Quality Management System. Metrics are communicated in management review to make informed decisions about the suitability of the QMS. A balanced scorecard can help companies identify the risks and prioritize areas for improvement. Well-developed metrics and scorecards can bring improvement opportunities and actions into focus.
Metrics and data are a key part of Management Review. Management needs to know how the quality system is performing, where the risks are, and where to invest precious dollars and resources for improvement. This course can help you determine what to measure, how to present information, and how to escalate issues for management review.
Bad data means bad decisions! Without proactive and timely metrics, a company is blind to the health of its quality system. Without metrics, a company can’t ensure they are meeting the needs of their stakeholders. This can lead to disaster for the company or, even worse, its customers. Medical device companies face ever-increasing scrutiny from the FDA and other regulators. Customers demand quality and safety. The business requires efficient and effective use of resources. And companies need a good set of metrics to meet these stakeholder needs.
Challenges that companies face include:
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 red flags and ways to ensure your management understands their responsibilities, is well informed on the health of the QMS, and provides the right level of oversight, attention, and resources.
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.