Live webinar on Managing the Medical Device Supply Chain By compliance2go June 21, 2012

Live Webinar on: Managing the Medical Device Supply Chain

Thursday, June 21, 2012 duration : 01:00 to 02:30 PM EDT



Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15



Pricing
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289
Get Training CD : $499

Who will benefit

This seminar is for all employees involved in supply management. In particular, it covers material valuable for cross-functional multi-discipline teams who manage supplies or commodities. This typically includes:
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• Purchasing Managers
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• Purchasing Professionals
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• Quality Managers
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• Quality Engineers
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• Manufacturing Engineers
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• Design Engineers

Supplier Quality Engineers

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About Speaker

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and holds an APICS certification in Resource Management



DESCRIPTION
The FDA regulations for medical devices define the requirements for supplier selection, management, and control. ISO 13485 includes similar requirements. In February 2009, the Global Harmonization Task Force (GHTF) released a guidance document on controlling products and services from suppliers. This guidance document has become the global de facto standard for supplier management. The seminar helps you understand the regulations and the expectations of the guidance document.
Supply chains for medical devices are important now and growing in importance as device manufacturers outsource products and services. As some of this outsourcing moves offshore and to low cost countries, the supply chain becomes longer, more diverse, and more difficult to control. The medical device manufacturer, however, has the ultimate responsibility for the product, so supply chain management becomes a critical function. This seminar explains the regulations and helps you implement the GHTF guidance document
Why Should You Attend

As part of their Quality Management System (QMS) requirements, manufacturers must evaluate, select, and monitor suppliers. As the supply chain becomes longer and more diverse, the methods of control become more difficult and the expectations of regulators become more stringent.
The best approach implements specific actions:
• Create clear requirements for supplier
• Evaluate potential suppliers against the criteria
• Create cross-functional multi-discipline teams that remain active beyond the selection process
The team approach, often called a commodity team or supplier team, is one of the most effective methods for supplier selection and management. The team needs to understand the requirements, implement the best practices in the GHTF document, and work with suppliers. This seminar provides the tools and techniques to help your teams manage the supplier base.
Attendees can get Free document by the Expert on GHTF/SG3/N17/2008 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

Areas Covered In the Seminar
• The FDA’s medical device regulations for supplier control
o Evaluation of suppliers
 Evaluation and selection
 Type and extent of control
 Records
o Purchasing data
 Requirements
 Change control agreements
 Control of purchasing data
o Items from the preamble
 The role of ISO 9001
 Performing suitable acceptance activities
 Approaches when audits are not practical
 Purchased or otherwise received – regardless of payment
 Sister facilities and corporate services
• ISO 13485:2003 purchasing requirements
o The purchasing process
 Evaluation and selection
 Type and extent of control
 Records
o Purchasing information
 Approval of product, procedures, processes, and equipment
 Qualification of personnel
 QMS requirements
o Verification of purchased product
 Inspection and other activities
 Verification at the supplier’s site
o Items from ISO/TR 14969:2004
 Supplier evaluation methods
 Examples of purchasing information
 Verification approaches
• GHTF Guidance
o Planning
 Identifying risks
 Establishing controls
o Selecting potential suppliers
 Business capability
 Operational capability
 Identification of potential suppliers
o Supplier evaluation and selection
 Establish criteria
 Evaluate potential suppliers
 An acceptable supplier
o Complete the control measures
 Supplier agreements
 Controls for second and lower tiers
o Delivery, measurement, and monitoring
 Monitor supplier performance
 Initiate correction, if necessary
 Initiate corrective action when appropriate
o Feedback and correspondence
 Positive and negative feedback
 Corrective action communication

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