Purchasing Controls for Medical Device Companies

Duration: 90 Minutes
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!
Instructor: Susanne Manz
Product ID: 501094
Purchasing Controls have received significant scrutiny from the FDA in recent years due to an increase in adverse events and recalls. Purchasing Controls continues to be a leading source of 483 and Warning Letter citations. Finished Device Manufacturers have had to deal with significant quality issues including recalls because of purchased materials and components.

Objectives of the Presentation
  • Understand FDA expectations for Purchasing Controls
  • Understand lessons learned from recalls and other major quality issues
  • Steps to developing effective purchasing controls
  • How the FDA will determine cracks in your process
  • How to manage your suppliers
  • Learn what documents the FDA will want to see
Areas Covered
  • Types of suppliers
  • Supplier evaluation
  • Determining the type and extent of control
  • Recordkeeping
  • Maintaining and disseminating purchasing data
  • Incoming material and acceptance activities
Why Should you Attend
Medical Device manufacturers routinely outsource some or all of their design, manufacturing, or other activities. However, suppliers of components and sub-assemblies are not independently required to comply with the Quality System Regulation (QSR). Therefore, it is imperative that finished goods manufacturers have processes in place to ensure the quality of any purchased products from suppliers.

Additionally, the QSR imposes Purchasing Control Requirements on finished goods manufacturer. Finished goods manufacturers must have a strong system in place to identify, evaluate, and monitor suppliers. They must be able to prioritize and determine the extent of controls required for each suppler.

Who can Benefit
  • Individuals new to Medical Device Companies
  • Supplier Quality Engineers
  • Compliance Personnel
  • Auditors
  • Managers and Individuals in Purchasing / Supplier Management
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor 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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. 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 while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) 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.

Susanne's new book on Medical Device Quality Management Systems - Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
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