Course Description:

Regulatory requirements for medical device companies seem to constantly undergo review and change, with increased emphasis on specific aspects based on recall, error and warning letter trends. Recent recalls of medical devices due to failures of critical components and services supplied to device manufacturers have resulted in increased scrutiny of Purchasing and Supplier Controls. The result is that manufacturers now 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.

But how do you account for all the raw material, components and services provided by your suppliers, let alone ensure they are aware of and comply with regulatory requirements?

In this two day seminar you will identify the various purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016, learn how these controls pertain to products, components and services, translate these requirements into actionable controls for your suppliers, and describe the links between purchasing controls and other quality system requirements such as design and acceptance activities. We will share current processes, challenges and best practices related to purchasing and supplier controls and develop quality plans for incorporating requirements and controls into your quality system.

Learning Objectives:

Upon completing this course, participants should be able to:

  • Understand the purchasing and supplier control requirements of the FDA QSR, EU MDR and ISO 13485: 2016
  • Evaluate effectiveness and applicability of these controls for their suppliers, raw materials, components and services using a risk based approach
  • Develop successful quality plans for incorporating requirements into the quality system
  • Select suppliers based on their capabilities to meet regulatory and manufacturing requirements
  • Establish procedures and records showing adequate supplier control
  • Establish robust and clear supplier agreements

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

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 – 4:30 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. Regulatory Requirements for Purchasing and Supplier Controls
    • FDA QSR
    • ISO 13485: 2016
    • EU MDR (proposed changes unless approved)
  3. Customer vs Supplier Requirements
    • Identification of Requirements
    • Reconciliation of Requirements
    • Mediation of Differences
  4. Identifying Purchasing Controls
    • Creating the Purchasing Process
    • Creating the Control Plan
    • Documentation of Specifications
    • Product/Service Evaluation
  5. Identifying Supplier Controls
    • Creating the Control Plan
    • Supplier Selection, Evaluation & Review
    • Control of Customer-Supplied Product
    • Receiving Inspection & Product Acceptance
    • Supplier Agreements
  6. Monitoring of Controls
    • Supplier Metrics
    • Internal Metrics

  1. Verification of Purchased Product
    • Incoming Inspection Activities
    • Identification & Traceability Requirements
  2. Using Risk to Evaluate Effectiveness & Applicability of Controls
    • Performing a Risk Assessment
    • Business Risk
    • Regulatory Risk
    • Product Risk
    • Risk vs Benefit Assessment
  3. Feedback & Communication
    • Manufacturer to Supplier
    • Changes to Specifications
    • Changes to Inspection Criteria
    • Changes to Regulatory Requirements
    • Supplier to Manufacturer
    • Changes to Supply
    • Changes to Equipment & Material
    • Changes Impacting Quality (known & unknown)
  4. Evaluation & Improvement
    • Auditing Suppliers
    • Supplier Corrective Actions
    • Supplier Scorecards
  5. Incorporating Purchasing & Supplier Controls into the QMS
    • Quality Manual
    • Operating Procedures- management review, CAPA, change control,
    • Work Instructions
    • Forms

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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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.

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Media Partners


Media Partner Benefits
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  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.

Local Attractions

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