Metrics and Management for a Suitable and Effective QMS

Speaker

Instructor: Susanne Manz
Product ID: 706489

Location
  • Duration: 90 Min
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.
RECORDED TRAINING
Last Recorded Date: Jul-2020

 

$399.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$499.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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
Instructor Profile:
Susanne Manz

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

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.

Frequently Asked Questions:

  1. How to implement the Check phase (Performance Evaluation) in the QMS according to ISO 9001:2015?
  2. How to make Management Review more useful in the QMS?
  3. How to comply clause for performance monitoring in line with our business. As a compliance obligation, we determined/set TAT for our frontline services and made it available to the public as a requirement. Our certifying body keeps on raising that we should have a means to monitor and analyze if we are meeting the TATs we set. So should we have to come up with a program to MONITOR if these TATs are met?
Follow us :

 

 

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. 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.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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2021 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method