This training session focused on developing an FDA and ISO 13485 compliant Quality Management System (QMS) for a medical device company.
WHY SHOULD YOU ATTEND?
To become equipped with the knowledge and tools necessary to develop, implement, and maintain a Quality Management System (QMS) that meets FDA and ISO 13485 standards for medical device companies. This training will provide a clear understanding of regulatory requirements, core QMS components, and best practices for compliance.
AREA COVERED
Overview of FDA and ISO 13485 Requirements
- Importance of FDA and ISO 13485 Compliance
- FDA Regulations (21 CFR Part 820)
- Key Requirements
- ISO 13485:2016 Standards
- Key Requirements
- Comparative Overview: FDA vs. ISO 13485
Preforming a Gap Analysis
Understanding the current company products and processes
Scope and Applicability
- Determining the applicable Elements of Quality Management System requirements
Implementing the QMS
- Steps for Effective Implementation
- Integration with Existing Processes
- Document Creation and Maintenance
- Training and Employee Engagement
Common Challenges and Best Practices
- Identifying Common Pitfalls
- Effective Strategies for Compliance
Q&A and Wrap-Up
- Open Floor for Questions and Discussion
- Summary of Key Takeaways
LEARNING OBJECTIVES
- Understand Regulatory Requirements: Develop a foundational understanding of the FDA regulations (21 CFR Part 820) and ISO 13485:2016 standards, including their similarities and differences.
- Identify Core QMS Components: Learn about the essential elements of a compliant QMS, including document control, risk management, design controls, and CAPA.
- Implement the QMS: Gain practical insights into the steps for implementing and integrating a QMS within the organization, ensuring effective documentation and training.
- Address Challenges: Recognize common challenges in achieving compliance and learn strategies to address them effectively.
WHO WILL BENEFIT?
- Quality Assurance/Quality Control (QA/QC) Managers
- Regulatory Affairs Specialists
- Compliance Officers
- Design and Development Engineers
- Production Managers
- Senior Management
To become equipped with the knowledge and tools necessary to develop, implement, and maintain a Quality Management System (QMS) that meets FDA and ISO 13485 standards for medical device companies. This training will provide a clear understanding of regulatory requirements, core QMS components, and best practices for compliance.
Overview of FDA and ISO 13485 Requirements
- Importance of FDA and ISO 13485 Compliance
- FDA Regulations (21 CFR Part 820)
- Key Requirements
- ISO 13485:2016 Standards
- Key Requirements
- Comparative Overview: FDA vs. ISO 13485
Preforming a Gap Analysis
Understanding the current company products and processes
Scope and Applicability
- Determining the applicable Elements of Quality Management System requirements
Implementing the QMS
- Steps for Effective Implementation
- Integration with Existing Processes
- Document Creation and Maintenance
- Training and Employee Engagement
Common Challenges and Best Practices
- Identifying Common Pitfalls
- Effective Strategies for Compliance
Q&A and Wrap-Up
- Open Floor for Questions and Discussion
- Summary of Key Takeaways
- Understand Regulatory Requirements: Develop a foundational understanding of the FDA regulations (21 CFR Part 820) and ISO 13485:2016 standards, including their similarities and differences.
- Identify Core QMS Components: Learn about the essential elements of a compliant QMS, including document control, risk management, design controls, and CAPA.
- Implement the QMS: Gain practical insights into the steps for implementing and integrating a QMS within the organization, ensuring effective documentation and training.
- Address Challenges: Recognize common challenges in achieving compliance and learn strategies to address them effectively.
- Quality Assurance/Quality Control (QA/QC) Managers
- Regulatory Affairs Specialists
- Compliance Officers
- Design and Development Engineers
- Production Managers
- Senior Management
