New ISO Standard for Medical Device Quality Systems 13485: 2016 Summary of its Impact to the Medical Device Industry Professionals

Description
You will gain a thorough insight into the specific quality system requirements of all new International ISO 13485:2016 Quality System Standard requirements for Medical Devices. This timely and extremely informative webinar will truly build your knowledge from the fundamental quality principles. It will help you grow into fulfilling the quality and regulatory requirements as a professional working for medical device manufacturers of fully assembled devices and global suppliers manufacturing critical parts for the medical device industry. All noteworthy changes implemented into this key international standard will be discussed to pave the path for implementation of the changes in your organization.

Objectives of the Presentation
You will gain a thorough understanding of changes to:
Quality Management System(QMS) Requirements of ISO 13485: 2016
Risk based approach to your QMS
Changes to management responsibility including expectations from management review
Competence and training requirements
Planning (design and development including transfer) and production controls
Elevation in CAPA expectations
Communication with regulatory authorities
Changes to supplier management
Correlation to FDA QSR 21 CFR 820 requirements

Why Should you Attend
You must attend this unique webinar presented by an expert trainer to add all the necessary tools to your quality, risk management, auditing and regulatory tool kit and lay the foundation to make the switch from ISO 13485: 2003 to the brand new ISO 13485:2016 Quality System Standard requirements for Medical Devices. Learning about the source and scope of the changes including the process of performing a gap assessment of your current quality system will help you to make a smooth seamless transition into the new requirements of this key international standard. This early understanding and implementation of the standard requirements will help you gain an edge in the arena of competitive global medical device marketing.

Areas Covered
Current vs future landscape in the ISO 13485world will be thoroughly examined
A quick comparison of how the new standard is harmonized with 21 CRF 820 and GHTF documents will be made
Alignment of the standard to cater to the Medical Device Single Audit Program MDSAP will be discussed
Extension of the quality system requirements to the life cycle of the medical device
Incorporation of customer feedback
Alignment with ISO 9001 and discussion of timeline for full implementation of ISO 13485: 2016
Regulatory expectations of other major growing geographies in the world
Details on ISO 13485:2003 elements changed in the new medical device standard ISO 13485: 2016
How risk management is incorporated into different sections of the international standard

Who can Benefit
This webinar will benefit Medical Device Company Managers, Supervisors, Leads, Specialists, Engineers and Groups in the Department of:
Quality Assurance
Design Engineers
Research & Development
Quality Control
Supplier Management
Upper Management
This webinar will benefit high to middle management
Manufacturing supervisors
Product leads
Quality specialists
Design engineers and document control departments

For Registration:

http://onlinecompliancepanel.com/webinar/NEW-ISO-MEDICAL-DEVICES-501379/MAY-2016-ES-WORLDCONCAL

Note: Use Promo code VBTPK and get 10% off on registration (Valid till May 31st 2016)