Developing Quality Objectives And Strategy for An Efficient And Effective QMS

Instructor: Susanne Manz
Product ID: 706160
Training Level: Intermediate to Advanced
  • Duration: 90 Min
This webinar will help you to develop strategy and objectives for an effective and efficient Quality Management System (QMS) for Medical Device Companies. A suitable and effective Quality Management System requires a thoughtful and methodical approach to create and execute. This webinar will help medical devices companies understand their current state and strategy for improvement. If you’ve had serious quality issues, compliance problems, or are dealing with the costs of an inefficient QMS, this webinar is for you.
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Why Should You Attend:

Regulators have ever increasing expectations for a suitable and effective QMS. Your customers demand quality products. And your business leaders and stakeholders expect an efficient QMS to optimize cost of quality. A thoughtful and well-executed strategy and objectives are required to meet these conflicting demands. An ineffective QMS can lead to serious compliance and quality issues including 483 observations, warning letters, and even consent decrees. Even worse it can lead to inconsistent of poor product quality including non-conformances, complaints, and even recalls. And an inefficient QMS leads to confusion, inconsistency, excessive rework, corrective and preventive action, and increased cost of quality. This webinar will help you develop a strategy and objectives to improve your QMS.

Learning Objectives:

  • Efficient and Effective QMS
  • Understand current state
  • Vision for Future State
  • Strategy, objectives, and techniques for improvement

Areas Covered in the Webinar:

This 90-minute webinar will include:

  • Current State
  • Key Capabilities
  • Visioning
  • Strategy
  • Objectives
  • Improvement techniques
  • Alignment
  • Communication

Who Will Benefit:

  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • Designated Management Representatives
  • Quality/Compliance managers or directors for Medical Device companies
  • General Managers wanting to learn how to understand Quality System requirements
  • Subject Matter Experts who write procedures
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.

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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.

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