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

By: Dan O'Leary, President at Ombu Enterprises, LLC
Location :- Sheraton Boston Hotel, MA | Thursday, June 28, 2018 | Friday, June 29, 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
  • Regulators
  • Quality and Sales Department Staff
  • Compliance Consultants
  • Senior Management

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 – The Role of the 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 Methods – Lot Acceptance Sampling Plans
    • Handling nonconformances
    • Detail Tools – Requests for Corrective Action
  • Part G – Supplier Monitoring and Measuring
    • Factors to Consider
    • Detail Tools – Defining Classical Metrics
    • Detail Tools – Implementing Predictive Methods
    • 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.

Venue

Location :
Sheraton Boston Hotel
39 Dalton Street,
Boston, MA 02199, USA
Tel: +1-617-236-2000

June 28-29, 2018


How to Reach

General Driving Directions: Logan International Airport (BOS)
  • Travel Distance: Approximately 9.66 km/6.0 miles
Other Transportation Subway
  • From outside the airport terminal, take any Silver Line bus to South Station.
  • Change at South Station for the Red line.
  • Take an Alewife-bound Red line train to Park Street.
  • Change at Park Street for the Green Line.
  • Take an “E-Heath Street” Green Line train to Prudential Station.
  • Exit Prudential Station into Prudential Center mall.
  • At center court, make a left into the Prudential Arcade, and the hotel will be just past Au Bon Pain
Bus
  • South Station to Travel Distance: Approximately 0.8 km/0.5 miles

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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$1,699

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June 28-29, 2018, Boston, MA

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Museum of Fine Arts
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Museum of Science
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North End
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Old North Church
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