World Compliance Seminars in Association with Be Quality Associates LLC Host Supplier Management for Medical Device Manufacturers 2 Day Seminar

Boston, MA -- (SBWire) -- 10/22/2015 --We invite you join us at 2 Day Seminar Supplier Management for Medical Device Manufacturers place at Boston,MA on Dec 03-04 ,2015.

Attend this highly-interactive workshop that will teach you how know the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation for supplier management.

REGISTER AND HEAR BY TOP SPEAKER

This two-day workshop will be led by Betty Lane who has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, while having a cost-effective Quality Management System. Her background in digital systems engineering enables her to facilitate implementation of design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation. Betty's training experience includes over 25 years of training on all aspects of FDA Quality System Regulation (cGMP) and ISO 13485, the ISO standard for Medical Device - Quality Management Systems for ASQ, AAMI, and colleges.

Early Bird Registration at $999 valid for only few attendees. Regular Price $1299 for 2 Day Pass
(Includes 12 RAC Recertification credits, 2 day workshop materials, Certficate & Breakfast)

What You Will Learn

Not only does this workshop provide you an opportunity to hear from an acknowledged expert in the subject , but you'll also share experiences and learn from your fellow attendees who are confronting the same issues as you.

Attend this critical workshop and you'll find out:

How to prepare yourself and your contract manufacturer for unannounced manufacturing audit
Understand FDA QSR and ISO 13485 requirements for supplier management
Creating a Risk-based Multi-tier supplier classification system
Understand when suppliers have to register and list with the FDA
Explain the link between design control and purchasing data
Develop a risk-based supplier management process
Incorporating supplier regulatory and safety risk
Incorporating supplier business risk
Defining and using supplier Metrics for measuring and monitoring of suppliers
Supplier audits, what is required and what is good practice

One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.

This seminar will not only review requirements and expectation of the FDA and European Notified Bodies for supplier management, but will guide you on how to incorporate these into your supplier management process.

This seminar will help you save your firm's significant efforts and resources, potentially saving millions of dollars by learning actionable approaches with improved awareness and familiarity.

Who Should Attend

This course will provide valuable assistance and guidance to all regulated companies. The following job titles/ positions will benefit from attending this seminar:

Quality Managers
Quality Engineers
Supplier Managers
Supplier Engineers
Internal quality auditors
Supplier auditors

But that's not all. There's one other way you'll benefit in a big way from attending WCS Supplier Management Seminar.

There's no doubt what a challenge it is to know the correct way that work for your staff and are also compliant with FDA regulations.

That's why, in the workshop materials, we've provided the following essential "exclusive materials:"

12 credits towards a participant's RAC recertification upon full completion

A set of detailed handouts

Two guidance documents referenced

GHTF Guidance document: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers

NBOG Guidance document: Guidance for Notified Bodies auditing suppliers to medical device manufacturers

Example Approved Supplier list

Example Supplier evaluation form

2 examples of Supplier QA Agreements

And more….

Building partnerships with your suppliers not only helps you meet FDA and ISO 13485 Notified Body requirements, but can add value to your quality management system and your company as well.

This two-day workshop is a rare opportunity to learn from an acknowledged expert … to rub elbows with colleagues who daily encounter the same issues that you do … to pick their brains … absorb their knowledge … and develop contacts who'll be invaluable to you all through the year.

Don't wait. Register TODAY or email us support@worldcompliancesemiars.com

Special Group discounts available call us on Toll Free 844-267-7299 to avail the same.

https://worldcomplianceseminars.com/seminardetails/6