DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices" conference to their offering.
This webinar will show you how to structure and optimize your QMS. It all starts with Management Responsibility and a commitment to quality.
We'll discuss the concepts of management responsibility, a culture of quality, and continuous improvement. We'll discuss tools and metrics for understanding the state of your QMS and how to identify and prioritize opportunities for improvement. We'll discuss the 4 major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections.
Throughout the seminar, we'll emphasize the regulatory expectations and how you can translate them into your QMS. In each section, we'll cover lessons learned from recalls, 483s, and warning letters. We'll discuss myths and challenges and how you can avoid common problems, and will discuss best practices that you can easily adopt and will set you off on the right foot.
- Intro to Quality System Regulations
- Management Responsibility
- Culture of Quality
- Metrics for monitoring and improving your Quality System
- Internal Audit is a secret to success
- Structuring your Quality Management System
- Document and Change Controls
- Writing Excellent SOPs
- Corrective and Preventive Action
- Root Cause Analysis
- Complaints and Medical Device Reporting
- Design Controls
- Intro to Risk Management
- Production and Process Controls
- Purchasing Controls
- Inspection Readiness
For more information about this conference visit http://www.researchandmarkets.com/research/947xbf/fda_concepts_for.