Outsourcing of key processes, use of contract manufacturers, and “virtual companies” are the norm in the U.S. medical device industry today. As companies seek to focus on core competencies, optimize operations, and reduce operating costs, activities are often outsourced to facilities where labor costs are lower and overhead expenses are greatly reduced. While Purchasing Controls are a regulatory requirement for medical device manufacturers, effective supplier management can make or break a company’s profit. Managing suppliers to support business needs while maintaining regulatory compliance becomes an ongoing challenge, and a daily reality for most manufacturers.
To address the industry’s need for ongoing education on purchasing controls, acceptance activities, and conformity to achieve an effective Quality Management Systems, AAMI introduces this new webinar CD, Solving Supplier Problems While Maintaining Compliance: Real World Examples.
Program content is focused on applying the principles described in the Global Harmonization Task Force’s Guidance on the Control of Products and Services Obtained from Suppliers to real-world supplier management issues. The webinar:
- Provides a brief summary of the GHTF guidance
- Describes case studies of various supplier problems related to finding qualified suppliers, monitoring supplier performance, and resolving quality problems
- Focuses on practical application of the GHTF guidance and industry best practices using real-world scenarios
- Explores options suited for small companies and larger firms
- Considers audience input in real time, and discuss pros and cons to various options for solving actual examples of supplier management challenges
Introduction: Brief Overview of GHTF Guidance
- Six Key Supplier Control Phases
Case Study discussions (numerous scenarios will be discussed)
- Background on a company and their QMS
- Background on their current supplier management issue
- Discussion of which aspects of supplier controls come into play for the scenario
- Summary of compliance concerns for the scenario
- Approaches to resolving the issue
- Interactive Ideas / Q&A from audience
Summary and Wrap-up
SPEAKERS - Industry Experts and AAMI Government Programs Faculty
- Tammy M. Pelnik, President, The St. Vrain Group, Inc.
- Andrew B. Snow, President, Momentum Solutions LLC
WHO WOULD BENEFIT FROM THIS CD
The webinar is designed for Quality Management System, Purchasing, and Supply Chain Management professionals. These individuals may represent medical device manufacturers, consulting businesses, European notified bodies and conformity assessment bodies, FDA, and other organizations that require information on effective implementation of supplier quality management methods used to meet regulatory requirements such as FDA's Quality System regulation, ANSI/AAMI/ISO 13485:2003, and GHTF’s guidance on outsourced products and services.
- Includes pdf of handout materials and webinar recording on CD.
- $295 for webinar registrants
- $395 for non-registrants
- Please note: Domestic and international shipping rates apply.
WAYS TO PURCHASE
- Phone - 1-800-373-3174 to order with a credit card.
- Fax - Select and download the order form and fax to 240-396-5781.
- Mail - Select and download the order form and mail with payment to:
PO Box 0211
Annapolis Junction, MD 20701-0211
For questions about ordering the CD, please contact Publications at 1-877-249-8226 or 240-646-7031.