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Purchasing Controls for Medical Devices

Faculty :

Industry :

Duration :

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.

Hear from our Speaker

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:

This 90-minute webinar will focus on establishing an effective and efficient system of purchasing controls. Topics to be covered include:
  • 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


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.




[Combo offer with this course]

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

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 ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena 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@complyarena.com or call +1-888-222-5917 (Toll Free).