· Validations; IQ, OQ, PQ · Internal Quality System Audits · Implementation of Quality System to achieve FDA and ISO Compliance · Hands-on Assistance to obtain ISO Certification · Quality Plans · SPC Set Up and Management · Incoming Inspection; Set up and Management · QE related Support for New Products-from Design to Manufacturing · Supplier Quality Engineering · Calibration & Gage Management-from Purchasing to Calibration · Training & Seminars · QE Recruitment · Others “How to obtain ISO 13485 certification and FDA QSR 21 part 820 compliance” When Date: Wednesday, Sept. 7 th, 2011 Time: 3:30 - 7:30 PM Joint us to discover the exciting world of quality assurance and regulatory compliance. This is the opportunity for you to become knowledgeable about the quality standards for the medical device industry. Obtain the power to lead the ISO 13485 certification process of your workplace as well as to accomplish the compliance with FDA QSR. This capability will make you a more competitive professional who is able to implement a quality management system in the medical device industry as well as in other fields. What is ISO 13485? International Standards Organization (ISO) 13485 – Quality Management System (QMS) for medical devices. This is essentially ISO 9001 tailored for medical devices. What is FDA QSR 21 part 820? The US government Code of Federal Regulations (CFR) Title 21, part 820 – The Quality System Regulation (QSR). This also commonly known as Good manufacturing Practices Seminar Cost: $295 400 Trade Center, Suite 5900 Who should attend? Quality Engineering Professionals - This seminar will reinforce one the basis of a Quality Engineering Role. It is critical that QE’s have a deep understanding of the industry standards so they can coach and support to accomplish the compliance of their workplace. R&D, Manufacturing and Engineering Professionals - This seminar will help them to improve their understanding of the industry standards, from the quality standpoint, so they can be effectively applied to their specific duties. Technical Discipline Professionals – You’ll get more familiar with the standards of the medical device industry. This seminar will help you to perform your job better as it makes you knowledgeable about the application of a quality system in your workplace. Technical Discipline Students - This is a great opportunity for you to get familiar with the medical device industry standards. This will make you a more competitive candidate for a job opportunity. Non-Medical Device Industry Professionals - Most of the principles of the medical device industry standards could be applied to other industries to achieve a good quality system for your workplace. This seminar will help you to know the tools available for you to assure quality in your company. To register please visit our website www.qescompany.com and go to the “contact us” tab; enter your registration information, specifying seminar code 2011-020. Once this is received you’ll get a pre-filled-out registration form via e-mail within 48 hours for you to return with your payment. Once the payment is received you’ll receive an e-mail with your training pass for the event. For additional information, write to us at
Services
QES provides the industry with professional and cost-effective solutions for the quality engineering needs. See below for some of our services:
Upcoming Seminar- Register Now!
Where:
Quality Engineering Solution – QES
Woburn, MA 01801
Light refreshment will be served!!
400 TradeCenter Suite 5900
Woburn, MA
978-885-1274
info@qescompany.com
