Why Should You Attend:
Bad data means bad decisions. 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. Without proactive and timely metrics, a company is blind to the health of its quality system. This can lead to disaster for the company or, even worse, its customers.
Management needs to know how the business is performing, where the risks are, and where to invest precious dollars for improvement. Challenges that companies face include:
Areas Covered in the Webinar:
Who Will Benefit:
Susanne Manz, MBA, MBB, RAC, CQA, 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. Ms. Manz also holds a Regulatory Affairs Certification (RAC) from RAPS and a Certified Quality Auditor (CQA) certification from the American Society for Quality. She has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Medical device companies need effective metrics and dashboards to ensure they are proactively and consistently meeting the needs of all their stakeholders:
Customers: It is critical to maintain metrics to ensure that your customers are receiving safe and effective products. Metrics that measure and trend product quality and customer satisfaction are critical. Fast or real-time systems are needed to ensure proper responsiveness.
Regulators: Proper metrics can help you identify, analyze, and mitigate compliance risks.
Business Stakeholders: Better decision making is enhanced by good data and information. Good metrics and scorecards help create a transparent environment where key indicators are proactively measured and addressed. Proper metrics should escalate and inform the appropriate levels of management.
A balanced scorecard can help companies identify the top areas for improvement. Well-developed metrics and scorecards can bring risks and improvement opportunities into focus. Thought should be given into both lagging and leading indicators for quality and compliance.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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