FDA INSPECTION ,SOP, COMPLIANCE TRAINING, CONFEREN 2012 - Live webinar on Managing the Medical Device Supply Chain By compliance2go

Website https://compliance2go.com/index.php?option=com_training&speakerkey=25&productKey=116 | Edit Freely

Category Training, web seminar,FDA,Japan,EU, pharmaceutical and biologic products, Life Science Industry, CE Marking, Medical Device R&D, Clinical research and medical operations

Deadline: June 21, 2012 | Date: June 21, 2012

Venue/Country: houston, U.S.A

Updated: 2012-06-12 00:12:00 (GMT+9)

Call For Papers - CFP

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.