Reduce Compliance and Recordkeeping Burdens

Why Should You Attend:

This webinar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You’ll learn to recognize sources of inefficiency in your QMS.

The information presented will not only help you get your quality system off to a good start and avoid common, but serious, problems including MDRs, recalls, 483s, and warning letters!

The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them.

This webinar will allow you to interact personally with an industry expert with over 30 years’ experience in medical devices. The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic. She has traveled throughout the world developing, auditing, and improving quality systems.

Learning Objectives:

• Regulatory Expectations
• How to plan, structure, and implement a quality system
• Common problems and lessons from 483 and warning letters
• Red flags that your QS is not effective or efficient
• Causes of inefficiency
• Six essential capabilities for an effective and efficient QMS
• Risk analysis and management techniques
• Process control and performance monitoring
• Culture, Management Responsibility, and maturity
• Strategies for improvement
• Improvement techniques

Areas Covered in the Webinar:

• Quality System Expectations
• Characteristics of an effective QMS
• Characteristics of an efficient QMS
• Sources of inefficiency
• Roles, responsibilities, capabilities
• Red Flags and warning signs
• Improvement tools and techniques
• Best Practices

Who Will Benefit:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Auditors
• Auditor Managers
• Compliance Managers
• Quality Managers
• CAPA Specialists
• Quality and Compliance directors for Medical Device companies
• General Managers and Executives wanting to use Compliance and Quality as a competitive strength

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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