ComplianceOnline

Purchasing Controls and Risk Management: How to Manage Resources in the Face of Increased Scrutiny by FDA and Other Regulators

Instructor: Edwin L Bills
Product ID: 701500
Training Level: Advanced
  • Duration: 75 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This purchasing control Webinar/ training will discuss how to use the tools of risk management in achieving safe and effective medical devices and reduce recalls due to failure of components, device or services supplied to device manufacturers.

Why Should You Attend:

Recent recalls of medical devices have included failures of components, devices, and services supplied to medical device manufacturers. The publication of a GHTF (Global Harmonization Task Force) guidance document for regulators of the medical device industry is also evidence of the growing concern by regulators of problems in this area. With a new emphasis in Purchasing Controls in the FDA and other regulators on suppliers to medical device companies, Risk Management will be an important tool for manufacturers to use in determining the level of control over suppliers and the potential requirements for involvement of the supplier in the various stages of product development.

We will discuss how to use the tools of risk management to efficiently manage resources in achieving safe and effective medical devices. We will also explore how to communicate risk management information throughout the development of the medical device and its manufacturing processes, both internal and external. The webinar will look at tools for determining appropriate level of control of supplied items, determining who is best to exert appropriate controls, and monitoring those controls.The use of risk management to perform to control purchased product.

Areas Covered in the seminar:

  • What are the concerns of regulators in the area of product, components and services provided to medical device manufacturers?
  • How can device manufacturers and suppliers efficiently manage resources and still meet regulatory concerns?
  • What tools can be used to determine where to focus resources?
  • What is "Essential Design Output"?
  • What is "appropriate level of control"?
  • How do designers communicate safety concerns to other appropriate parts of the device manufacturer's organization and the supplier's organization?
  • What additional requirements of manufacturers can be expected by suppliers?

Who will benefit:

This webinar is focused on the relationship between medical device manufacturers and their suppliers in the area of products supplied. The regulatory requirements on the device manufacturer will be explored and techniques for meeting those requirements will be discussed.
  • QA managers and personnel
  • Quality system auditors
  • Process validation specialists
  • Product design managers
  • Supplier Management personnel
  • Medical device supplier process and design personnel
  • Regulatory Affairs
  • Risk Managers

Instructor Profile:
Edwin L. Bills, During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group.

Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.

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