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  • Product id  :  IQW15C8371

    Purchasing Controls: Medical Devices

Speaker
: Susanne Manz
Schedule
: Tuesday, February 21, 2017 | 10:00 AM PST | 01:00 PM EST
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Duration
: 90 Mins
Level
: Intermediate
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  • Description
  • Why should you attend
  • Areas covered
  • Who will benefit
  • Speaker
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. Additionally, finished Device Manufacturers have had to deal with significant quality issues including recalls because of purchased materials and components. 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!
Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; quality problems that can manifest during assembly or later in the field; non-conformances and scrap on your manufacturing lines; or even MDRs and recalls. 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.
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
  • Planning
  • Evaluation of Suppliers
  • Purchasing Data
  • Performance Management
  • Feedback and Communication
  • Best Practices
  • Supplier Engineers
  • Supplier/Purchasing Managers
  • Quality Engineers
  • Supplier Quality Engineers
  • Compliance Personnel
  • Supplier Auditors
  • Compliance Specialists

Susanne Manz 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. She 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.

 

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