Introduction to ISO 13485 Quality Management System for Medical Devices

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SUMMARY
This is a no-miss presentation is for any manufacturer or distributor of medical or dental device products looking to opportunities beyond U.S. borders. It provides the participant with an in-depth introduction to the international standard for medical devices. Many countries including all EU member states, Canada, Japan and Australia require registration to ISO 13485:2003 in addition to demonstrated compliance with other regulatory requirements issued by country or union. This training is intended for individuals within amedical device manufacturing firms responsible for implementation,coordination and management of company quality management system witheither impending or ongoing registration to ISO 13485:2003.

INSTRUCTOR:
John Dahlgren (click for instructor profile)

DATES & TIMES

August 25, 2010 at 1:00 p.m. EST | 10:00 a.m. PST

Please check your time zone for the correct local time

LENGTH

Two Hours

PRICE

$259

WHY TAKE THIS COURSE?
By attending you will understand:

The difference between ISO 13485:2003 and previous versions of medical device quality standards (ISO 9001:1994 + ISO 13485:1996)
The interactions of each of the primary clauses in the process-based quality system
The stand-alone requirements of each of the primary clauses in the process-based quality system
The basis of a quality manual in a process-based quality system as a means to develop quality objectives
The interactions between ISO 13485:2003 Quality Management System and medical device regulations

WHO SHOULD ATTEND THIS WEBINAR

Individuals responsible for and who interact with a medical device quality management system
Quality and regulatory professionals including: Managers, Directors, Audit team members
Upon entering the course it is recommended that the webinar attendee is familiar with the ISO 13485:2003 Medical Device Quality Management System and Medical Device Regulations – FDA QSR, MDD, CMDR and JPAL

COURSE OUTLINE

The webinar attendee with be presented with an overview of the process-based quality standard
The webinar attendee will be presented with ISO 13485:2003 overview by process elements:

Clauses 1, 2, 3 and 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis and Improvement

The webinar attendee will be presented with a dive into each of the above clauses, their interactions and stand-alone requirements
The webinar attendee will be presented with an overview of medical device regulation and interaction with the ISO standard

BONUS!

Unlimited viewing of the recorded version of this webinar for 14 days
Certificate of attendance for each PAID participant
Get your specific questions answered in a live Q&A session during the webinar

HOW DOES THIS ALL WORK?
After you register for the Webinar, you will receive a confirmation e-mail. It will contain a Web link to access the visual portion of the event through your Web browser. It will also contain an a phone number and access code that you will use to hear the audio portion of the event. Please note that you may incur phone charges.

PRICING
We are so confident that you will find this webinar valuable that we offer a 100% money back guarantee, making this a risk-free investment. If you are dissatisfied with the webinar, just let us know by phone or e-mail within 24 hours of the conclusion of the webinar, and we will issue you a full refund.

PLEASE NOTE: Participation in this webinar is just $259 per site and allows access to ONE Internet connection and ONE phone line.

Price: $259.00


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