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FDA Scrutiny of Purchasing/Supplier Controls

By:
Lena Cordie, Quality & Regulatory Consultant
Coming soon.. Please contact customer care for new schedule

Course "FDA Scrutiny of Purchasing/Supplier Controls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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:

Lunch
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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Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Suite 200
Palo Alto, CA 94303
USA

Group Registrations

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

2 Attendees - Get 10% off
3 to 6 Attendees - Get 20% off
7 to 10 Attendees - Get 25% off
10+ Attendees - Get 30% off

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Payment:
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).

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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.

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.

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