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Virtual Seminar on A Process Approach to Quality Management Systems

6-Hour Virtual Seminar

Online Event, Your Computer

This 6-hour webinar covers strategies to improve the effectiveness and efficiency of a Quality Management System (QMS) for medical device companies.

An effective yet efficient quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This seminar will get you started in setting up just such a Quality System.

We'll discuss using a process approach for creating an effective and efficient QMS.

In this webinar, we will discuss:
  • Regulatory Expectations
  • How to plan, structure, and implement a quality system
  • Defining the processes and resources that work together to create an effective and efficient QMS
  • Process ownership
  • Process control and performance monitoring
  • Characteristics of a fully established process

Why you should attend

The FDA Quality System Regulation requires medical device companies to establish a suitable and effective quality management system (QMS). And ISO 13485:2016 is based on a process approach to quality system management. This webinar will help you interpret these regulatory requirements and translate them into a quality system that is both effective and efficient.

You'll learn how to structure and define the processes within your QMS to ensure effective processes with no gaps and overlaps in coverage creating problems. You’ll learn to recognize sources of inefficiency and ineffectiveness in your QMS.

This seminar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters! 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 or 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. An inefficient QMS results in wasted time, money, and missed opportunities. It is imperative that medical device companies can effectively and efficiently establish a QMS.

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 seminar 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

Students will understand the regulations, context, and history of quality system regulations.They will learn concepts and techniques for developing a quality management system that is both effective and efficient. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference:
  • Quality System Expectations
  • Case for Quality
  • Characteristics of an effective QMS
  • Characteristics of an efficient QMS
  • Common problems
  • QMS architecture and structure
  • A process approach
  • Key processes
  • Identification and interaction of key processes
  • Process management
  • Roles, responsibilities, capabilities
  • Process control and performance monitoring
  • Red Flags and warning signs
  • Improvement tools and techniques
  • Inspection preparedness and management
  • 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 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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Time: 08:00 AM PDT | 11:00 AM EDT

  • Regulatory expectations
  • Lessons Learned from 483s and warning letters
  • Common problems, mistakes, and warning signs
  • How to structure your QMS
  • Quality policy and manual requirements
  • QMS structure, hierarchy, and documents
  • Roles and responsibilities
  • Key capabilities
  • Best practices
  • Vision, strategy, and planning

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Event details
Organizer : Global Compliance Panel
Event type : Webinar
Reference : ASDE-22305