New ISO Standard for Medical Device Quality Systems 13485: 2016 Summary of its Impact to the Medical Device Industry Professionals Webinar training seminars presented by Online Compliance Panel register now on FindaSeminar.com

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

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This webinar will benefit Medical Device Company Managers, Supervisors, Leads, Specialists, Engineers

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Seminar Summary:

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.  (see full course description)

 

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Training Course Syllabus:


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

Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 75 Minutes

Instructor: Meena Chettiar


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.

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.

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

Seminar Summary:

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.  (see full course description)

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