Dublin, Jan. 31, 2022 (GLOBE NEWSWIRE) -- The "Medical Device Quality Systems, CAPA and European Medical Device Regulations" training has been added to ResearchAndMarkets.com's offering.
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 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.
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
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
Key Topics Covered:
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
For more information about this training visit https://www.researchandmarkets.com/r/fc17xm
