ComplianceOnline
Course "Designing a Supplier Qualification Program" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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:

Lunch
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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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.

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