Course Description:

Manufacturers bear the responsibility for every step in their supply chain to ensure they provide quality finished medical devices beyond what can be achieved through testing and inspection, meaning overall quality depends on quality of raw materials, components and services. In addition, manufacturers must make sure that all aspects of the supply chain are compliant with regulatory and quality system requirements. To do this, it is critical that manufacturers evaluate and approve product and service suppliers prior to issuing a Purchase Order, but what is a supplier qualification program?

This 1.5-day seminar outlines the supplier qualification process and requirements and provides how-to information for designing (or redesigning) a sustainable and regulatory compliant supplier qualification program.

Learning Objectives:

Upon completing this course, participants should be able to:

  • Define the requirements for a sustainable and regulatory compliant supplier program
  • Explain how change controls, quality plans and other quality programs feed into the supplier qualification program

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

  • Apply risk-based approaches to the supplier selection process and incorporate into a quality management system
  • Create audit checklists, supplier assessments, scorecards and other qualification tools to use in the pre-selection, selection and assessment process
  • Document approve supplier lists, supplier agreements, quality agreements and other supplier documentation
  • Classify, rank, monitor, re-qualify, and disqualify suppliers through performance measurements
  • Conduct on-site and off-site verifications

Who will Benefit:

This course is designed for people responsible for following purchasing procedures, those tasked with developing and improving purchasing and supplier controls including approval of suppliers, components, raw materials and services, and individuals responsible for quality management system improvements and compliance.

Following personnel will benefit from the course:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Purchasing supervisors
  • Manufacturing engineers
  • Design engineers
  • Quality engineers
  • Document control specialists

Course Outline:

DAY ONE (8:30 AM – 4:30 PM) DAY TWO (8:30 AM – 1:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Understanding the Basics of a Quality Management System
    • Terms & Definitions
    • References & Standards
    • Quality Principles
  2. Components of a Supplier Qualification Program
    • Regulatory Requirements (FDA QSR & ISO 13485)
    • Supplier Requirements
    • Supplier Type Classifications
    • Audit Checklists
    • Supplier Files
    • Approved Supplier List
    • Supplier Reviews
    • Standard Operating Procedures (SOPs) and other quality documentation
  3. Incorporating Supplier Qualification into a QMS
    1. Change Control
    2. Complaint Handling
    3. Corrective & Preventive Action
    4. Deviation Management
    5. Quality Plans
    6. Sales
  4. Supplier Assessment & Evaluation
    • Supplier Requirements
    • Documentation of Requirements
    • Budget Considerations
    • Information Required from Supplier
    • Supplier Assessment & Evaluation

  1. Supplier Qualification & Review
    • Approval & Qualification
    • Supplier Classification
    • Continuous Monitoring & Routine Review
    • Supplier Scorecards
  2. Supplier Disqualification & Re-Qualification
    • Criteria for Disqualification
    • Reasons for Re-Qualification
    • Documentation & Processes
  3. On-Site & Off-Site Audits
    • Audit Checklist
    • Documentation Review
    • Audit Report
    • Communication of Findings – Supplier Corrective Actions

Meet Your Instructor

Lena Cordie
Quality & Regulatory Consultant

Ms. Cordie has over 20 years experience in quality and regulatory affairs in the medical device, call center and retail markets, specializing in integrating electronic QMS modules, implementation of agile labeling programs, including color labels and barcodes, and cleanrooms for medical device production. She has been a member of Regulatory Affairs Professionals Society (RAPS) since 2005.

Key Surgical products focus on Central Sterile Departments and Ms. Cordie represents the company as a voting member of the Association for the Advancement of Medical Instrumentation (AAMI) since 2007. Ms. Cordie is very active in a number of working groups drafting Sterilization Standards related to surgical instrument cleaning and reprocessing and is a US delegate to the ISO/TC 198 Sterilization of Health Care Products committee.

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Payment Mode

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ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002

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Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.

Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

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