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Medical Device Quality Systems, CAPA and European Medical Device Regulations (February 14-15, 2022)

  • ID: 5516639
  • Training
  • February 2022
  • Region: Europe
  • 2 Days
  • Compliance Online
  • Training Dates: February 14-15, 2022

Medical Device Companies must meet the regulatory requirements to “establish and maintain” a quality management system (QMS). This 2-day seminar will cover the essentials of compliance 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 virtual 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. This course will cover the essential for creating a QMS that is both effective and efficient.

This 2-day virtual seminar, 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
  • Monitor and measure
  • Audit for self-awareness
  • Risk analysis and management techniques
  • CAPA, continuous improvement, and six sigma
  • Culture, Management Responsibility, and maturity
  • Management review and responsibility
  • Key Quality System elements and linkages

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 create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then 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 of 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 is a published author and has traveled throughout the world developing, auditing, and improving quality systems.

Learning Objectives:

Day 1:

  • Comparison of Quality System Regulation (21 CFR 820) to ISO13485:2016
  • Principles of a Quality Management System
  • Regulatory Expectations
  • How to “Establish and Maintain” a Quality System with Excellent Standard Operating Procedures
  • Process Approach
  • Practical Approaches to an Efficient and Effective Quality Management System
  • Lessons Learned from Warning Letters

Day 2:

  • Improvement Approaches
  • Corrective and Preventive Action
  • Good Documentation
  • Root Cause Analysis
  • Tool Kit
  • Inspection Readiness
Note: Product cover images may vary from those shown

Day 01 (8:00 AM - 3:00 PM PST)

08.00 AM: Session Start

8:00 AM -9:30 AM

  • Quality Management System Requirements for Medical Devices
  • Key Responsibilities
  • Process Approach to Quality Management Systems
  • Differences between QSR and ISO 13485
  • Lessons Learned
  • Key Capabilities

9:30 AM -9:45 AM: Break
9:45 AM -11:15 AM

  • Measurement, and Analysis
  • Metrics
  • Key Process Indicators
  • Management Review
  • Metrics Board

11:15 AM -11:30 AM: Break
11:30 AM -1:00 PM

  • Internal Audit for self-awareness
  • Risk management
  • Inspection Readiness

1:00 PM -1:30 PM: Lunch
1:30 PM -3:00 PM

  • Excellent Standard Operating Procedures
  • Establish and Maintain
  • QMS Structure
  • Complete and concise
  • Mistake Proofing
  • Documentation Practices

Day 02 (8:00 AM - 3:00 PM PST)

8:00 AM -9:30 AM

  • Regulatory Expectations
  • Lessons Learned
  • QSR vs. ISO13485
  • GHTF Guidance
  • Developing an Overall CAPA Program

9:30 AM -9:45 AM: Break

9:45 AM -11:15 AM

  • Sources of DATA
  • Analysis of Data
  • CAPA Process

11:15 AM -11:30 AM: Break

11:30 AM -1:00 PM

  • Non-conforming material
  • Failure Investigations
  • Recalls
  • Toolkit
  • Connections
  • Risk Management
  • Common Problems and Solutions
  • Inspection Readiness

1:00 PM -1:30 PM: Lunch

1:30 PM -3:00 PM

  • Root Cause Analysis
  • Good Documentation
  • Inspection Readiness
  • Best Practices
Note: Product cover images may vary from those shown
  • Susanne Manz Susanne Manz,
    President and Principal Consultant ,
    Manz Consulting, Inc.

    Susanne Manz 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. She 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.

Note: Product cover images may vary from those shown
  • Quality System Specialists
  • Internal Auditors, Managers, and Directors
  • CAPA Specialists
  • Compliance Managers or Directors
  • Process Owners
  • Quality Managers
Note: Product cover images may vary from those shown