2-Day Virtual Seminar

Medical Device Quality Systems, Quality System Regulations, and CAPA

BY: Susanne Manz, President and Principal Consultant, Manz Consulting Inc

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

Coming soon.. Please contact customer care for new schedule
  • Course Description
  • Agenda
  • Speaker
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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’ 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
  • nspection Readiness
Who will benefit:
  • Quality System Specialists
  • Internal Auditors, Managers, and Directors
  • CAPA Specialists
  • Compliance Managers or Directors
  • Process Owners
  • Quality Managers
Day 01(8:00 AM - 3:00 PM PST)
  • 08.00 AM: Session Start
  • 8:00 AM: Module 1
    • 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: Break
  • 10:00 AM: Module 2
    • Measurement, and Analysis
    • Metrics
    • Key Process Indicators
    • Management Review
    • Metrics Board
  • 11:30 AM: Break
  • 11:45 AM: Module 3
    • Internal Audit for self-awareness
    • Risk management
    • Inspection Readiness
  • 1:15 PM: Break
  • 1:30 PM -3:00 PM: Module 4
    • 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: Module 1
    • Regulatory Expectations
    • Lessons Learned
    • QSR vs. ISO13485
    • GHTF Guidance
    • Developing an Overall CAPA Program
  • 9:30 AM: Break
  • 10:00 AM: Module 2
    • Sources of DATA
    • Analysis of Data
    • CAPA Process
  • 11:30 AM: Break
  • 11:45 AM: Module 3
    • Non-conforming material
    • Failure Investigations
    • Recalls
    • Toolkit
    • Connections
    • Risk Management
    • Common Problems and Solutions
    • Inspection Readiness
  • 1:15 PM: Break
  • 1:30 PM -3:00 PM: Module 4
    • Root Cause Analysis
    • Good Documentation
    • Inspection Readiness
    • Best Practices
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Susanne Manz
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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