FDA Concepts for Medical Device Companies - Regulations, Myths, Challenges, and Best Practices – GlobalCompliancePanel 2016

OVERVIEW:
This seminar 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 understand 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.

 

Time: 9:00 AM to 6:00 PM
Why should you attend?
An efficient and effective Quality Management System (QMS) is a critical success factor for all Medical Device Companies and is necessary for you to meet the needs of all of your stakeholders. A QMS needs to be effective to ensure your products are safe and effective for your customers. It needs to ensure compliance to the regulations and enable you to successfully demonstrate that compliance to the regulators. But, a QMS system also needs to be efficient to allow you to meet the needs of your business stakeholders and shareholders.

 

This seminar will introduce you to the Quality System Regulations and how to translate them into a QMS that can be both nimble and rigorous in ensuring safe and effective products. You will understand the essential capabilities for managing an excellent Quality System.

Areas Covered in the Session:

• Expectations for Medical Device Quality Management Systems
• Regulations
• Quality Management System Structure and Processes
• Lessons Learned
• Myths
• Challenges
• Best Practices
• Inspection Readiness

Who will benefit:

• Quality Engineers
• Process Engineers
• Design Engineers
• Compliance Specialists
• Quality and Compliance Managers
• CAPA Specialists
• Auditors
• Senior Management wanting an overview of Quality Systems and Management Responsibility
• Anyone wanting an introduction to Quality Management Systems

AGENDA:

Day 1 Schedule:

Lecture 1:

• 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

Lecture 2:

• Structuring your Quality Management System
• Document and Change Controls

Lecture 3:

• Writing Excellent SOPs

Lecture 4:

• Corrective and Preventive Action
• Root Cause Analysis

Day 2 Schedule:

Lecture 1:

• Complaints and Medical Device Reporting

Lecture 2:

• Design Controls
• Intro to Risk Management

Lecture 3:

• Production and Process Controls
• Purchasing Controls

Lecture 4:

• Inspection Readiness

 

Speaker: Susanne Manz
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, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne 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 Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Others Details

For more details and updates please visit website