Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar  

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training seminars by ComplianceOnline ComplianceOnline   

For:

Quality Managers, Supply Chain Managers, Quality Engineers, Supplier Quality Engineers, Purchasing Professionals, Regulatory Specialists, Production and Process Engineers, Design and Development Engineers, Verification and Validation Specialists

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Seminar Summary:

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. (see full course description)

 

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Training Course Syllabus:


Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar

Course Description:

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.

  • How well do you understand the requirements for supplier management?
  • Could you pass a regulatory audit or inspection without any issues?
This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.

This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the supplier’s location, supplier auditing techniques, and supplier issues in management review.

The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation.


Learning Objective:
Upon course completion, participants will:

  • Understand FDA QSR and ISO 13485 requirements for supplier management
  • Understand the FDA’s multi-tier supplier classification system
  • Understand when suppliers have to register and list with the FDA
  • Use an analysis matrix and radar chart to compare suppliers
  • Explain the link between design control and purchasing data
  • Develop an overall supplier management plan
  • Understand how to develop and implement supplier controls
  • Create receiving inspection criteria and apply them as part of supplier controls
  • Create supplier measurement and monitoring systems
  • Create a system for supplier business risk
  • Create a system for supplier regulatory risk
  • Create a risk based system for supplier audits
  • Develop a supplier audit using the backward trace process approach

Course Outline:

DAY 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

Part A – Regulatory Requirements

Part B – Planning for Supplier Management

Part C – Planning for Supplier Selection

Part D – Potential Suppliers

DAY 02(8:30 AM - 4:30 PM)

Part E – Supplier Selection

Part F – Implementing Supplier Controls

Part G – Monitoring, Measuring, and Evaluation

Part H – Feedback and Communication

Part I – Evaluating your program

Seminar Summary:

This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. (see full course description)

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