Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls! This virtual seminar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control. You’ll learn about the essential elements of purchasing control and how you can translate them into your procedures. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continue to be a leading source of 483 and Warning Letter citations. This course will examine real-life warning letters to deepen your understanding of important concepts
Learning Objectives:
- Understand QSR 820.50, 820.80, and ISO13485:2016
- Understand GHTF guidance
- FDA QSIT approach to inspection
- FDA authority over medical device manufacturers and their suppliers
- Develop a risk-based approach to supplier audits
Who will Benefit:
- Quality Managers
- Supplier Engineers
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Supplier Auditors
- Compliance Specialists
- Product and Process Engineers
- Design Engineers
In-Person Seminar going Virtual with increased learner satisfaction.
Yes, attend this seminar from anywhere. We are making it real and more interactive - Here's a sneak peek:
Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:
- The real-time and live presentation as in in-person events
- Private chat for company-specific conversation - the same as you would get in an in-person seminar
- Opportunities to connect with your peers to share knowledge at a different time and have group discussions
- Live workshop activities
- Live Q&A during the event and offline Q&A assistance after the event
- As usual more content, activities and case studies and now adding homework for a comprehensive understanding
- Certification
Susanne Manz, President and Principal Consultant, Manz Consulting Inc
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Worldwide Director of Design Quality, Worldwide Director of Product Quality, Executive Business Consultant, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification from RAPS and Quality Auditor 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.
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Time: 9:00 AM - 3:30 PM EDT
Venue
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