Say what you do; Do what you say; and Prove it! Quality Management System Essentials

Why Should You Attend:

The expectation of regulators to “establish” a QMS is a broad requirement that must be well understood to create a suitable and effective system. Form 483 and warning letters frequently contain observations about “failure to establish”. 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 understand and efficiently meet the requirements to establish a suitable and effective Quality Management System.

Learning Objectives:

• Overview of the Regulations
• Concept of “establish and maintain”
• FDA Expectations
• Lessons Learned and Common Mistakes
• Best Practices
• Preparing for an FDA Inspection

Areas Covered in the Webinar:

This 90-minute webinar will include:

• FDA expectations
• Lessons Learned from 483s and warning letters
• Common problems, mistakes, and warning signs
• How to effectively “say what you do”
• How to effectively “do what you say”
• How to effectively “prove it”
• Best Practices

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

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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