Medical Device Quality Systems, CAPA and European Medical Device regulations 2021

Medical Device Quality Systems, CAPA and European Medical Device regulations 2021

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.

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

Who will Benefit:

• Quality System Specialists
• Internal Auditors, Managers, and Directors
• CAPA Specialists
• Compliance Managers or Directors
• Process Owners
• Quality Managers