FDA Scrutiny of Purchasing/Supplier Controls
Lena Cordie, Quality & Regulatory Consultant
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||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.
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.
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:
USB with seminar presentation
Hard copy of presentation
$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
|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
- Understanding the Basics of a Quality Management System
Regulatory Requirements for Purchasing and Supplier Controls
- Terms & Definitions
- References & Standards
- Quality Principles
Customer vs Supplier Requirements
- FDA QSR
- ISO 13485: 2016
- EU MDR (proposed changes unless approved)
Identifying Purchasing Controls
- Identification of Requirements
- Reconciliation of Requirements
- Mediation of Differences
Identifying Supplier Controls
- Creating the Purchasing Process
- Creating the Control Plan
- Documentation of Specifications
- Product/Service Evaluation
Monitoring of Controls
- Creating the Control Plan
- Supplier Selection, Evaluation & Review
- Control of Customer-Supplied Product
- Receiving Inspection & Product Acceptance
- Supplier Agreements
- Supplier Metrics
- Internal Metrics
- Verification of Purchased Product
Using Risk to Evaluate Effectiveness & Applicability of Controls
- Incoming Inspection Activities
- Identification & Traceability Requirements
Feedback & Communication
- Performing a Risk Assessment
- Business Risk
- Regulatory Risk
- Product Risk
- Risk vs Benefit Assessment
Evaluation & Improvement
- 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)
Incorporating Purchasing & Supplier Controls into the QMS
- Auditing Suppliers
- Supplier Corrective Actions
- Supplier Scorecards
- Quality Manual
- Operating Procedures- management review, CAPA, change control,
- Work Instructions
Meet Your Instructor
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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