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Who should attend FDA Scrutiny of Purchasing/Supplier Controls
Quality professionals, Regulatory professionals, Compliance professionals, Purchasing supervisors, Manufacturing engineers, Design engineers, Quality engineers
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


FDA Scrutiny of Purchasing/Supplier Controls

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

Course Outline:
DAY ONE (8:30 AM – 4:30 PM)

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

Session Start Time: 9:00 AM

Understanding the Basics of a Quality Management System
Terms & Definitions
References & Standards
Quality Principles
Regulatory Requirements for Purchasing and Supplier Controls
FDA QSR
ISO 13485: 2016
EU MDR (proposed changes unless approved)
Customer vs Supplier Requirements
Identification of Requirements
Reconciliation of Requirements
Mediation of Differences
Identifying Purchasing Controls
Creating the Purchasing Process
Creating the Control Plan
Documentation of Specifications
Product/Service Evaluation
Identifying Supplier Controls
Creating the Control Plan
Supplier Selection, Evaluation & Review
Control of Customer-Supplied Product
Receiving Inspection & Product Acceptance
Supplier Agreements
Monitoring of Controls
Supplier Metrics
Internal Metrics

DAY TWO (8:30 AM – 4:30 PM)

Verification of Purchased Product
Incoming Inspection Activities
Identification & Traceability Requirements
Using Risk to Evaluate Effectiveness & Applicability of Controls
Performing a Risk Assessment
Business Risk
Regulatory Risk
Product Risk
Risk vs Benefit Assessment
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)
Evaluation & Improvement
Auditing Suppliers
Supplier Corrective Actions
Supplier Scorecards
Incorporating Purchasing & Supplier Controls into the QMS
Quality Manual
Operating Procedures- management review, CAPA, change control,
Work Instructions
Forms

Seminar Summary:

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. (see full course description)

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