Purchasing Controls for Medical Devices
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Course Description:
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:
- Understanding the regulations
- Lessons Learned
- FDA Expectations - Authority and Scope
- Purchasing Controls Process 1: Planning
- Planning
- Evaluation of Suppliers
- Purchasing Data
- Performance Management
- Feedback and Communication
- Best Practices
Who will benefit?
This webcast will be of a valuable assistance to the below audience.
- Supplier Engineers
- Supplier/Purchasing Managers
- Quality Engineers
- Supplier Quality Engineers
- Compliance Personnel
- Supplier Auditors
- Compliance Specialists
Registration Options
Tags
Purchasing Controls, Supplier Control, QMS, Manufacturing Lines, FDA, 483 and Warning Letter citations, FDA Expectations, Medical Device, FDA Medical Devices, FDA approved Medical Devices, FDA Regulations for Medical Devices, Medical Device Safety, GHTF Regulatory Requirements, MDRs and recalls
Speaker Details
Susanne Manz
Medical Device Consultant
Susanne Manz, MBA, MBB, RAC, CQA 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
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
