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Two days Workshop On ISO 13485:2016 Quality Management Systems


Thursday, February 23, 2017 at 9:00 AM - Friday, February 24, 2017 at 4:00 PM (PST)

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Ticket Type Remaining Sales End Price Fee Quantity
Single Registration
Special Group Discount 2 Attendees - Get 10% off 3 to 5 Attendees - Get 20% off 5+ Attendees - Get 30% off
30 Tickets Ended $1,400.00 $61.95

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Course "Quality Management Systems that Comply with ISO13485:2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.








   Lena Cordie - Owner/Principal Consultant, Qualitas Professional Services, LLC





Course Description
The medical device industry is in the midst of major change, with the publication of the FDA's UDI Regulation, the first revision to the ISO Quality Management Systems standard in over a decade, and the upcoming changes to the EU's Medical Device Regulation expected to be passed later this year. All of these events have a far reaching effect on Quality Management Systems. So, it is critical to understand what has changed within ISO 13485: 2016 in order to create a comprehensive quality plan for your organization to ensure continued compliance and certification.

This interactive session will include lectures, round table discussions and activities all aimed at understanding key strategies and identifying specific actions to effectively improve Quality Management System Compliance. The program will also include detailed step-by-step guidance on how to develop, implement and maintain strategies in order to achieve a specific goal. Participants will want to come to the sessions with a thorough knowledge of improved company strategies and a willingness to discuss aspects of it in a confidential learning environment.

Learning Objectives

  • Gaining an understanding of the relationship between standards and quality management systems
  • Understanding the basic principles of a quality management system
  • Incorporating the Plan-Do-Check-Act approach
  • Identifying the critical elements of a quality system
  • Creating a documentation structure that is consistent with the system requirements
  • Assessing and applying risk throughout the quality system
  • Comparing the requirements of ISO 13485 to the FDA QSR
  • Understanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016
  • Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016
  • Establishing a plan for implementing the revised requirements of ISO 13485: 2016

Who will Benefit
Executives, Directors, Senior Managers and Functional Managers from the Medical Device Industry with responsibilities in the following areas. We encourage the participation of more than one person from each company to facilitate the creation and implementation of your action plans.

  • Quality Management Systems
  • Quality Assurance
  • Regulatory Affairs
  • Risk Management
  • Project Manager
  • Design Controls
  • Compliance
  • Standards & Regulations
  • Labeling
  • Packaging
  • Sterilization
  • Operations.
For Registration

Note: Use Promo code HYULK and get 10% off on registration (Valid till FEBRUARY 29th 2017)
Have questions about Two days Workshop On ISO 13485:2016 Quality Management Systems? Contact onlinecompliancepanel

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When & Where

1400 6th Ave,
Seattle, WA 98101

Thursday, February 23, 2017 at 9:00 AM - Friday, February 24, 2017 at 4:00 PM (PST)

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Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. Online Compliance Panel believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. Online Compliance Panel closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

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Two days Workshop On ISO 13485:2016 Quality Management Systems
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