Vendor and Supplier Qualification Program for FDA Regulated Industries


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The FDA regulates manufacturers of medical products such as devices, pharmaceuticals, tissue products, and biologics. However, the regulations don’t usually extent to suppliers. Instead, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industries.

An effective supplier qualification program has some specific elements including determining expectations and requirements, identifying potential suppliers, evaluating them, selecting a supplier, and re-evaluating the selected suppliers. When issues arise, the manufacturer communicates with the supplier and manages corrective action.

The result is a supplier qualification program that address two principle questions:

  • Which suppliers are good enough to start doing business with you
  • Which suppliers should continue to do business with you

This workshop explains an overarching supplier qualification program that is common to FDA regulated medical product manufacturers. It also provides the details of the various program areas such as devices, pharmaceuticals, etc.

An effective supplier qualification uses tools and techniques. The workshop explains particularly relevant tools such as supplier audits, metrics, scorecards, acceptance verification, and corrective action. These techniques help make the program FDA compliant and robust.

Why You Should Attend:

An effective supplier qualification program can prevent problems and save money. The goal is to ensure that competent suppliers provide products and services correctly and on time. This saves cost and helps you provide good products to your customers. In addition, an effective supplier qualification program meets the regulatory requirements; you will not need to worry about an FDA 483 or a Warning Letter. This workshop provides the information you need to establish and manage an effective program.

Learning Objectives:

Participants learn the elements of an effective supplier qualification program for FDA regulated medical products.

  • Define a sustainable supplier qualification program
  • Understand how to set expectations and requirements
  • Learn how to identify potential suppliers
  • Understand methods to evaluate potential supplier’s for their ability to meet your requirements
  • Know how to select suppliers based on the evaluation
  • Learn the requirements to keep records – a key component for FDA compliance
  • Learn sound methods to specify the products and services from suppliers
  • Understand how to evaluate received products and services, including statistical techniques
  • Learn the techniques to monitor and measure supplier performance
  • Understand how to re-evaluate suppliers and keep records
  • Learn methods to improve or replace poor performers
  • Understand supplier qualification tools including audits and performance evaluation

Who Will Benefit:

  • Purchasing Managers
  • Quality Managers
  • Supplier Quality Engineers
  • Audit Managers
  • Compliance Managers
  • Law Department Managers
DAY 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • Part A – Overview of a Supplier Qualification Program
    • Determining expectations and requirements
    • Identifying potential suppliers
    • Supplier evaluation
    • Supplier selection
    • Supplier measuring and monitoring
    • Supplier re-evaluation
    • Supplier communication
    • Supplier corrective action
  • Part B – Regulatory Framework for Suppliers
    • Device regulations
    • Tissue product regulations
    • Pharmaceutical regulations
    • Biologicals regulations
    • Commonality and differences
    • Guidance documents
  • Part C – Requirements and Potential Suppliers
    • Defining requirements
    • Documenting expectations
    • Identifying potential supplier
    • Communicating requirements and expectations
    • Reviewing the responses
  • Part D – Supplier Evaluation and Selection
    • Comparing Requirements to Responses
    • Using Comparative Tools – The Radar Chart
    • Using Comparative Tools – The Cost of Ownership
    • Detail Tools – The Onsite Audit
    • Detail Tools – Evaluation the Virtual Company
    • Detail Tools – Debarment and Similar Issues
    • Supplier Selection and Records
DAY 02(8:30 AM - 4:30 PM)

  • Part E – Placing Purchase Orders
    • Defining Contractual Information
    • Purchasing Information
    • Written Quality Agreements
  • Part F – Receiving Product and Services
    • Verification
    • Statistical Methods – Lot Acceptance Sampling Plans
    • Handling nonconformances
    • Detail Tools – Requests for Corrective Action
  • Part G – Supplier Monitoring and Measuring
    • Factors to Consider
    • Detail Tools – Classical Supplier Metrics
    • Detail Tools – Predictive Supplier Metrics
    • Communicating the Results to Management
    • Communicating the Results to the Supplier
  • Part H – Supplier Re-evaluation
    • Identifying Poor Performers
    • Retaining Suppliers
    • Get Well Programs
    • Disqualification of Suppliers
  • End of Workshop
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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