Courses

Purchasing Controls & Supply Chain Management Course

 

Program-At-A-Glance

 

Day One

 
  • Introduction
  • Definitions and Regulatory Requirements
  • Planning
  • Supplier Selection
 

Day Two

 
  • Supplier Selection (cont)
  • Defining Supplier controls
  • Day-to-Day Operations
  • Communications and Improvements
 

Day Three

 
  • Integrating Supplier Controls throughout the Quality Management Systems
  • Supply Chain Management
  • Submissions and Compliance
 

Link to detailed agenda

This day course provides extensive information on effective implementation of supplier selection and controls. This detailed course covers the key aspects of supplier controls, from planning for supplier assessment/selection, to defining acceptance activities, to monitoring supplier performance. Each topic is presented from a practical perspective, with links to the requirements of the Quality System regulation, the ISO 13485 standard, risk management considerations, and pertinent Global Harmonization Task Force guidances.

The course also covers life-cycle management approaches for a medical device manufacturing organization’s supply chain.  The course includes substantial “hands-on” exercises to allow attendees to apply concepts and interact with colleagues, and provides specific industry examples.

Objective

Upon completing this course participants will be able to evaluate their organization's compliance with FDA's requirements for purchasing controls and acceptance activities, and consider appropriate risk mitigation strategies for supplied products and services.

Who Should Attend?

This course is targeted to professionals involved in establishing supplier agreements, supplier quality management, purchasing activities, Quality System compliance, and regulatory submissions for significantly outsourced products.

Dates & Hotels

DATES LOCATION PHONE & RATES
April 22-24, 2013 The Westin Arlington Gateway
801 North Glebe Road
Arlington, VA 22203
Website
703-717-6200
$209 single/double
Rate through: 3/24/2013
NOTE: Reservation request should be made as soon as possible, but no later than the 'rate through' date listed above. Rooms are assigned on a first-come, first-served basis and may sell out prior to the deadline.

Faculty

Faculty for AAMI's training programs are drawn from an experienced group of professionals from the medical device industry, academia, and FDA. The mix of industry leaders and regulatory experts ensures a balanced presentation of requirements and paths to quality system compliance, as well as an improved understanding of industry practices and standards application. In addition, the opportunity to hear FDA interpretations and expectations firsthand has been cited as one of the most valuable aspect of AAMI's programs.

Fee and Registration

Fee includes PowerPoint presentations and case studies; relevant standards and technical information reports; pertinent FDA documents and additional references; and continental breakfast, lunch, and refreshments. Click here to go to registration.

REGISTRATION TYPE
FEES
AAMI corporate and institutional member
$1735
AAMI individual member
$1835
Nonmember
$2135
Government employee
$635

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