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Event Details


Strategies for Improving Effectiveness and Efficiency of your Quality Management System

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Who should attend?

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


This two-day seminar will cover the essentials of an effective yet efficient Quality management system for medical device companies. An efficient and effective 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 the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.

In this webinar, we will discuss:

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

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

Why you should attend:

This seminar will help you understand regulatory requirements and how to translate them into a Quality System that is both effective and efficient. You'll learn how to plan, structure, and implement a Quality System specific for your business needs. We'll explore the capabilities that every medical device company needs to ensure quality products and a compliant Quality System. We'll discuss how to define your current situation and create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then, we will move on to continuous improvement, Six Sigma, and Corrective and Preventive Action to address issues within your Quality System. You'll learn how to effectively communicate and escalate risk as well as monitor performance and progress.

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!

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:

Using interactive discussion and exercises, 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

Characteristics of an effective QMS

Characteristics of an efficient QMS

Roles, responsibilities, capabilities

Quality leadership and a seat at the table

Vision, Strategy, and Planning

Case for Quality

Red Flags and warning signs

Improvement tools and techniques

Inspection preparedness and management

Best Practices


Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)


John Robinson

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