The FDA's New Emphasis on Supplier Controls? Is Your Company Ready?

Instructor: Vinny Sastri
Product ID: 701609
Training Level: Intermediate
  • Duration: 90 Min

recorded version

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This presentation will detail the expectations and the details of the new GHTF guidance document on “the Controls of Products and Services Obtained from Suppliers” published in December 2008 and also discuss how these new requirements affect suppliers and what suppliers need to do to be ready for further evaluations and audits that their customers will be conducting in the future. It will also focus on how design and development, risk management and process controls are intricately linked to purchasing controls.

Why Should You Attend:
Purchasing Controls has always been an integral part of the Medical Device Regulations (21 FCR Part 820 Section 820.50). It calls for medical device manufacturers to "ensure that all purchased or otherwise received product and services conform to specified requirements". However due to the recent incidents of contaminated heparin, peanut butter, and pre-filled syringes, melamine in milk, lead in toys and diethylene glycol in toothpaste, more emphasis is going to be placed on medical device manufacturers to have stricter controls over their suppliers. Moreover, warning letters with respect to supplier controls have increased over the last 3 years. A recent GHTF guidance document ( ) describes the process and requirements. The new emphasis on supplier controls by the FDA is based on this guidance document.

It is the responsibility of the medical device manufacturers to provide the detailed requirements and specifications to their suppliers and exert the appropriate levels of controls (in terms of product quality, no change agreements, supplier audits, material tests and requirements etc.). The level of controls will depend upon the risk of the device and hence the criticality and risk of the components and parts that go into those devices.

This Webinar will discuss the importance of purchasing controls. What are the levels of controls that need to be exerted based on device and product risk and classification. The participant will also understand the elements of the supplier control process and develop and maintain appropriate procedures to control suppliers, materials and services.

Areas Covered in the Seminar:

  • Introduction and the reasons for the new emphasis on supplier controls.
  • Quality Management Systems and Purchasing Controls.
  • Purchasing controls and the relationship to:
    • Design Controls
    • Production and Process Controls
    • Process Validation
    • Risk management
  • Developing raw material, components and service requirements, specifications and acceptance criteria.
  • The GHTF Supplier Controls Guidance Document.
    • Planning
    • Selection of potential suppliers
    • Supplier evaluation and acceptance
    • Finalization of controls and responsibilities
    • Delivery measurement and monitoring
    • Feedback and communication including Corrective and Preventive action process
  • Supplier Audits.
  • Preparing for the future.

Who Will Benefit:

This Webinar is designed for people involved in the specifications and purchase of raw materials, components and services. This typically includes:
  • Supplier Quality managers and personnel
  • Regulatory directors and managers
  • Business managers
  • Risk Management personnel
  • Design and development directors, managers, engineers and technical personnel
  • Quality Directors, Managers and Engineers
  • Production and Process Directors, Managers and Engineers
  • Manufacturing Managers and Engineers
  • QA and QC managers, inspectors, supervisors and personnel

Instructor Profile:
Dr. Vinny Sastri, Ph.D., is the President of WINOVIA® LLC and has over 25 years experience in new product development and quality management with a strong track record in the healthcare, medical device, electronics, plastics and the automotive industries. He is a certified Six Sigma black belt. WINOVIA assists companies increase their growth and profitability via customized solutions, strategies, training and implementation of effective, self-sustaining new product development and quality management processes. Areas of expertise include quality systems, product design and development, design controls, manufacturing and process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, risk management, CAPA and materials.

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