Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Susanne Manz

OVERVIEW:
This webinar 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 webinar 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.

Why should you Attend: 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.

Areas Covered in the Session:
– Understanding the regulations
– Lessons Learned
– FDA Expectations
– Purchasing Controls Process
– Planning
– Evaluation of Suppliers
– Purchasing Data
– Performance Management
– Feedback and Communication
– Balance between purchasing control and receiving inspection
– Best Practices
– Inspection Readiness

Who Will Benefit:
– Supplier Engineers
– Supplier Auditors
– Supplier/Purchasing Managers
– Quality Engineers
– Supplier Quality Engineers
– Compliance Personnel
– Compliance Specialists

SPEAKER PROFILE:
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.