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

ComplianceOnline

Thursday, April 6, 2017 at 8:30 AM - Friday, April 7, 2017 at 4:30 PM (PDT)

Supplier Management for Medical Device Manufacturers:...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration(Early Bird Price)
Registrations after March 20, 2017 - $1899
Apr 6, 2017 $1,299.00 $0.00
Seminar One Registration (With 2 Nights Stay) Apr 6, 2017 $2,099.00 $0.00
Seminar One Registration Apr 6, 2017 $1,899.00 $0.00

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Event Details

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.

In addition to the discussion material, the course includes multiple exercises, guidance documents, and templates/tools to help you implement an effective program.

 

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

 

Who will Benefit:

  • 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



For Registration - http://www.complianceonline.com/supplier-management-for-medical-device-manufacturers-seminar-training-80131SEM-prdsm?channel=eventbrite

 

Note: Use coupon code < NB5SQH8N > and get 10% off on registration.

Have questions about Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar? Contact ComplianceOnline

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When & Where


San Francisco

San Francisco, CA

Thursday, April 6, 2017 at 8:30 AM - Friday, April 7, 2017 at 4:30 PM (PDT)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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