Using lecture, discussion, and exercises, this 2 day seminar will focus on taking your QMS from surviving to thriving. We'll move from understanding the regulatory requirements, how to create your QMS structure, process thinking, and developing your improvement strategy. We'll discuss tools and techniques for improvement and how to measure your progress.
Why Should You Attend?
Many companies struggle to establish and maintain a Quality Management System (QMS) that is both efficient and effective. An ineffective QMS leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. An ineffective QMS can result in serious consequences for your customers leading to dissatisfaction, serious injury, or even death. It is imperative that medical device companies can effectively establish a QMS.
And an inefficient QMS results in wasted time, money, and missed opportunities. In this 2-day seminar, we will use lecture, exercises, and discuss to learn the fundamentals of a Quality Management System and how you can take your program from surviving to thriving. A thriving QMS can help you achieve your compliance objectives and improve product quality, leading to higher customer satisfaction and business results.
Areas Covered in the Session:
- Essentials of an effective QMS
- Essentials of an efficient QMS
- Quality is not an Organization
- Key Capabilities
- Maturity Modeling
- Vision, Strategy, and Quality Planning
- Improvement Tools
- Best Practices
Time: 9:00 AM to 6:00 PM
Day 1 Schedule
- Regulatory expectations for a QMS
- Lessons Learned from 483s and warning letters
- Common problems and simple solutions
- QMS Structure
- Roles and Responsibilities
- Management Responsibility, Culture of Quality, Risk Management
- Key Capabilities for success
- Maturity Modeling
- QMS Evolution
Day 2 Schedule
- Metrics, internal Audit
- Cost of Quality
- Quality Leadership
- Vision and Strategy
- Quality Planning
- Improvement Tools and Techniques
- CAPA and RCA
President and Principal Consultant ,
Manz Consulting, Inc.
Susanne Manz 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. She 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.
- Quality Systems Specialists
- Quality and Compliance Specialists
- Quality and Compliance Managers and Directors
- CAPA Specialists
- Project Managers
- Supplier Quality Engineers and Auditors
- Quality Engineers
- Management Representatives
- General Managers
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