ISO 13485:2016 Transition Training


The most recent version of the ISO 13485 Standard places more prominence on product regulatory requirements, software systems validation, risk management, sterile device processing, post market surveillance and vigilance activities, a full life cycle quality management system and a clear departure from ISO-9001. This course is for individuals who are already familiar with the ISO 13485:2003 Standard for the medical device industry and are involved in transitioning their company to ISO 13485:2016, including planning, implementation and supervisory activities. It is also ideal for auditors who will audit to the new standard.

The course covers:
• Changes to the standard and their impact on a company’s QMS and Internal Audit Program
• The Annex SL framework (organizational context, leadership, planning and support)
• Methods for meeting and auditing new requirements, including risk management and organizational knowledge
• The business approach on how to use your ISO 13485-based QMS to benefit the performance of the company

The course concludes with a panel discussion focused on subtleties of both refreshing a currently installed quality system and implementing the ISO-13485(2016) standard for the first time. The panel will include Kimberly Briggs, who has more than 20 years of FDA regulatory experience specializing in the medical device field.

Participants will be able to identify gaps in their company’s current QMS and be prepared to plan the transition to the ISO 13485:2016 revision.

Prerequisites: Knowledge of ISO 13485:2003 and key principles of a QMS

Course Schedule:

Start Date: 06/20/2018
Time: 8:00 am To 5:00 pm

Instructor Bio: John B. Riggi

Mr. Riggi has 40 years of experience in quality assurance and regulatory affairs management at major companies, including Bausch & Lomb, Novartis and Baxter Healthcare. In each role, he has been responsible for global quality system design, manufacturing quality and regulatory compliance. He began his career with implementation of quality systems, as per requirements of the initial 21CFR820 regulation. He has overseen medical device compliance to 21CFR820, ISO-9001 and ISO-13485, as well as product regulatory compliance.

ISO 13485:2016 Transition Training

Date(s): June 20 and 21, 2018

Time: 8:00 AM To 5:00 PM

Venue: UB's Technology Incubator / Baird Research Park

Format:Classroom Based

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