Skip Main Navigation
Page Content

Save This Event

Event Saved

2 Day Seminar Supplier Management for Medical Device Manufacturers

worldcomplianceseminars

Thursday, June 1, 2017 at 8:30 AM - Friday, June 2, 2017 at 4:00 PM (EDT)

2 Day Seminar Supplier Management for Medical Device...

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration May 31, 2018 $993.00 $0.00
Special Group Discount Register for Four attendees May 31, 2018 $3,495.00 $0.00

Who's Going

Loading your connections...

Share 2 Day Seminar Supplier Management for Medical Device Manufacturers

Event Details

2 Day Seminar Supplier Management for Medical Device Manufacturers

Location 1: Boston -- Jun 01 - 02,2017
Hilton Garden Inn Boston Logan Airport ($169 / night)
Address: 100 Boardman St, Boston, MA 02128, United States
Phone: +1 617-567-6789
Call our customer care to get the Hotel details Toll Free 844-267-7299

An Interactive Workshop Presented BY Betty Lane - President Be Quality Associates, LLC
Attend this highly-interactive workshop that will teach you why FDA QSR and ISO 13485 requirements for supplier management



REGISTER AND HEAR BY TOP SPEAKER

This two-day workshop will be led by Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Early Bird Registration at $993 valid for only few attendees .Regular Price $1399 for 2 Day Pass
( Includes 12 RAC Recertification credits , 2 day workshop materials ,Certificate & Breakfast )



Description

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to device manufacturers, 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. 
Building partnerships with your suppliers not only helps you meet FDA and ISO 13485 Notifed Body requirements, but can add value to your quality management system and your company.

Since FDA regulations do not allow FDA to audit your suppliers, unless that supplier makes finished medical devices, FDA requires that you have sufficient control over your suppliers. From time to time the FDA makes a reinterpretation of what this means. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The “c” stands for current, meaning what the FDA considers the current state-of-the-art in the areas they regulate. This happened for supplier management within the last few years. So if you supplier management program has not been updated in the last few year, you might need to make major changes to it. In addition European Notified Bodies periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG). 

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation for supplier management.  
One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.  
This seminar will not only review requirements and expectation of the FDA and European Notified Bodies for supplier management, but will guide you on how to incorporate these into your supplier management process.    

Free Handouts for Attendees:  

--  Two guidance documents referenced  
GHTF Guidance document: Quality Management System Medical DevicesGuidance on the Control of Products and Services Obtained from Suppliers  
NBOG Guidance document: Guidance for Notified Bodies auditing suppliers to medical device manufacturers  
--  Example Approved Supplier list  
--  Example Supplier evaluation form  
--  2 examples or Supplier QA Agreements

Areas Covered

**  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

Who will Benefit

== Quality Managers  
== Quality Engineers  
== Supplier Managers  
== Supplier Engineers  
== Internal quality auditors  
== Supplier auditors.

Learning Objectives

-- 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..



But that's not all. There's one other way you'll benefit in a big way from attending WCS Supplier Management for Device Manufacturers .
There's no doubt what a challenge it is to know the How Notified Body unannounced audits affect your contract manufacture

That's why, in the workshop materials, we've provided the following essential "exclusive materials:"

--- 12 credits towards a participant's RAC recertification upon full completion
---  A set of detailed handouts
---  Two guidance documents referenced  
GHTF Guidance document: Quality Management System Medical DevicesGuidance on the Control of Products and Services Obtained from Suppliers  
NBOG Guidance document: Guidance for Notified Bodies auditing suppliers to medical device manufacturers  
--  Example Approved Supplier list  
--  Example Supplier evaluation form  
--  2 examples or Supplier QA Agreements ..
        Certificate Signed By the Top FDA Speaker
        And more….

They'll help you Planning the Supplier Management Program  with confidence.
This two-day workshop is a rare opportunity to learn from an acknowledged expert … to rub elbows with colleagues who daily encounter the same issues that you do … to pick their brains … absorb their knowledge … and develop contacts who'll be invaluable to you all through the year.

Don't wait. Register TODAY or email us. View Course Outline:

Special Group discounts available call us on Toll Free 844-267-7299 to avail the same.

Have questions about 2 Day Seminar Supplier Management for Medical Device Manufacturers? Contact worldcomplianceseminars

Save This Event

Event Saved

When & Where


Hilton Garden Inn Boston Logan Airport ($169 / night)
100 Boardman St
Boston, MA 02128

Thursday, June 1, 2017 at 8:30 AM - Friday, June 2, 2017 at 4:00 PM (EDT)


  Add to my calendar

Organizer

worldcomplianceseminars

We provide Custom Corporate Training, onsite Business Seminars and Employee Development Workshops designed to improve employee & company performance. Our training and consulting services are delivered on your schedule and designed around your budget.

  Contact the Organizer
2 Day Seminar Supplier Management for Medical Device Manufacturers
Things to do in Boston, MA Class Other

Please log in or sign up

In order to purchase these tickets in installments, you'll need an Eventbrite account. Log in or sign up for a free account to continue.