Vendor and Supplier Qualification Program for FDA Regulated Industries: 2-day In-person Seminar

By: Dan O'Leary, President at Ombu Enterprises, LLC
Location :- San Diego, CA | Thursday, September 27, 2018 | Friday, September 28, 2018

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Course Description:

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

Course Outline:

Day One (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 – Onsite Audit
    • Detail Tools – Evaluation the Virtual Company
    • Detail Tools – Debarment and Similar Issues
    • Supplier Selection and Records
Day Two (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 Tool – 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

Meet Your Instructor

Dan-O-Leary
Dan O'Leary
President at Ombu Enterprises, LLC

Daniel O'Leary has more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Master’s Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Mr. O'Leary is a regular speaker at international conferences including ASQ, ISM, and RAMS. He teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary is an ASQ certified biomedical auditor, quality auditor, quality engineer, reliability engineer, and Six Sigma black belt; he holds an APICS certification in resource management.

Location :
San Diego, CA
(Venue to be announced shortly)
September 27-28, 2018
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$1,499

Seminar One Registration

September 27-28, 2018, San Diego, CA
(Registrations till August 18, 2018 - $1499)
(Registrations till September 3, 2018 - $1699)
(Registrations after September 3, 2018 - $1899)

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