Seminar on Supplier Management for Medical Device Manufacturers training seminars presented by Global Compliance Panel register now on FindaSeminar.com

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Seminar on Supplier Management for Medical Device Manufacturers  

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By:

Global Compliance Panel   

For:

Quality Managers, Quality Engineers, Audit Managers, Supplier Engineers, Internal quality auditors, Supplier auditors, Quality associates, Quality Specialists, Regulatory Compliance Managers

Cost:   

see Registration info for seminar cost, group discount etc.

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:


Seminar on Supplier Management for Medical Device Manufacturers

Overview:


Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. 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 suppliers' 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.

Areas Covered in the Session:

Understand FDA QSR and ISO 13485 requirements for supplier management
Creating a Risk-based Multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Defining and using supplier Metrics
Explain the link between design control and purchasing data
Develop an risk-based supplier management process
Incorporating supplier regulatory and safety risk
Incorporating supplier business risk
Create supplier measurement and monitoring systems
Understand the how to develop and implement supplier controls
Create a risk based Value-added system for supplier audits
How to prepare yourself and your contract manufacturer for unannounced audits from your Notified body
Creating acceptance criteria and understand how that fits into your supplier control process

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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