Enjoying the Summer!
Date: Wednesday, July 12, 2017
Location: Paradise Pier Hotel, Disneyland Resort; Anaheim, California USA
The NEW ISO 13485:2016 has been released. Prepare now for your implementation or transition to ISO 13485:2016. This course will discuss the new ISO 13485:2016, explain the differences from the previous version (ISO 13485:2003), and what needs to be modified in a FDA (21 CFR Part 820) compliant Quality System in order to be compliant with the requirements of ISO 13485:2016 including the additional requirements for compliance in Canada and the European Union. Changes to your Quality System must be done properly in order to comply and be certified by a registrar or notified body. The medical device world is becoming more global and by opening up a company's geographic reach, it can significantly increase its potential market. Many U.S. companies have realized that by modifying their U.S. FDA compliant Quality System to comply with the requirements of ISO 13485, Canada, and European Union's Medical Device Directive (MDD, see Thursday's CE Marking course)) requirements they can gain substantial market potential. Areas such as Europe (EU), Canada, Australia, Asia, and Central & South America either accept ISO 13485 or a modified version of it (i.e. nationalized to their own needs)...in all that's a huge global market! Vendors, Suppliers and Contract Manufacturers also benefit with compliance to ISO 13485:2016 in terms of marketing their quality commitment and reduced customer audits. Done properly, integrating compliance to all four requirements (U.S. FDA QS regulation, ISO 13485:2016, Canadian Medical Device Regulations (CMDR), and EU MDD) into one quality system will require minimal impact to your company without needing to run & maintain 4 separate quality systems. This course will be beneficial to Management, Quality, Regulatory, R&D, and Marketing personnel including Executive Management, vendors/suppliers/contract manufacturers to medical device manufacturers, and any other groups or departments impacted by the quality system that want to understand the impact of adding the additional compliance requirements to their daily responsibilities. One of the goals of this course is to teach how to integrate ISO 13485:2016, Canadian MDRs, and EU MDD requirements into an FDA QSR/GMP compliant quality system; individuals not familiar with the FDA Quality System Regulation (21 CFR Part 820) or needing a refresher will find it very beneficial to also attend the FDA QSR/GMP course on Monday.
What you will learn:
Benefits of Attending:
Abbreviated Outline Draft:
: Airfare Discounts, Pricing, Discounts, Continuing Education Units Awarded, Speaker Biographies, Past Participants, Sights to see in the area.
Be sure to reserve your space and room early!