FDA Inspection ,SOP, Compliance Training, conferen 2012 - Live webinar on Managing the Medical Device Supply Chain By compliance2go

Why you should 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

Description of the topic

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.

Areas Covered In the Seminar

The FDA’s medical device regulations for supplier control
Evaluation of suppliers
Evaluation and selection
Type and extent of control
Records
Purchasing data
Requirements
Change control agreements
Control of purchasing data
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
The purchasing process
Evaluation and selection
Type and extent of control
Records
Purchasing information
Approval of product, procedures, processes, and equipment
Qualification of personnel
QMS requirements
Verification of purchased product
Inspection and other activities
Verification at the supplier’s site
Items from ISO/TR 14969:2004
Supplier evaluation methods
Examples of purchasing information
Verification approaches
GHTF Guidance
Planning
Identifying risks
Establishing controls
Selecting potential suppliers
Business capability
Operational capability
Identification of potential suppliers
Supplier evaluation and selection
Establish criteria
Evaluate potential suppliers
An acceptable supplier
Complete the control measures
Supplier agreements
Controls for second and lower tiers
Delivery, measurement, and monitoring
Monitor supplier performance
Initiate correction, if necessary
Initiate corrective action when appropriate
Feedback and correspondence
Positive and negative feedback
Corrective action communication

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:
Purchasing Managers
Purchasing Professionals
Quality Managers
Quality Engineers
Manufacturing Engineers
Design Engineers
Supplier Quality Engineers

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.