Metrics and Management for a Suitable and Effective QMS

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.

Purchase using Webinar All-Access Pass
One User Unlimited access to all recorded webinars for 6 Months

Recorded Version Only

(PPT + Recorded Streaming Link)

1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Sep-2021

Download File Only

(PPT + Recorded Training File)

Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
Customer Care

Fax: +1-650-362-2367


Follow us:
Why Should You Attend:

Many medical device companies are surprised when they have a recall, a 483, or even a warning letter. To prevent 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.

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 or metrics to meet these stakeholder needs.

Challenges that companies face include:

  • Lack of data
  • Data that is not timely
  • Data that is incorrect or statistically incorrect
  • Metrics that are not balanced leading to improper use of resources and unintended consequences
Areas Covered in the Webinar:

  • Determining Key Process Indicators
  • How to create a balanced scorecard
  • How to move from lagging to leading indicators
  • How to use indices or profiles to create a more complete picture of performance
  • Lack of transparency in quality/compliance data
  • Use of metrics and dashboards for management review
  • Maturity levels in use of metrics
  • Scalability and hierarchy in metrics
  • Creating a Metrics Board for your company
Who Will Benefit:
  • Managers of Quality and Compliance
  • Directors of Quality and Compliance
  • Process Owners wishing to monitor and improve their processes
  • Individuals preparing data for Management Review
  • Management Representatives
  • General Managers wanting greater insight into Quality Metrics and Data
  • Auditors
  • Compliance Specialists
  • Quality Engineers

From medical device companies

Instructor Profile:
Susanne Manz Susanne Manz

President and Principal Consultant, Manz Consulting Inc/p>

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. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Refund Policy

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. FDATrainingAlert 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.

If you have any concern about the content of the webinar and not satisfied 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 call +1-888-771-6965 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

You Recently Viewed