Most medical devices are subject to design controls requirements defined by a global set of regulations, standards, and guidance to ensure the safety and effectiveness of these products. Design controls alone, however, are not sufficient to address all of the needs of a medical device development program. To address this gap, organizations employ some variation on a product development process to integrate design controls requirements with more general program management needs.

This seminar provides an overview of design controls requirements and proposes two models for incorporating these requirements into a more comprehensive product development process. The first proposal assumes a serialized “V-model” approach to product development and steps the attendee through the combination of design controls and other program activities in a stage gate process. The second proposal assumes an iterative model (e.g. Agile Scrum, SAFe) and applies variations of stage gate processes depending on the degree of iteration required and the complexity of the program.

The seminar will recommend both compliance and program management tools to move organizations through each stage gate. There will also be a discussion of the Quality Management System, as a subset of a Business Management System, which will provide clarity regarding those activities crucial to safety, efficacy, and compliance, as contrasted with important program activities that go beyond the scope of quality and regulatory compliance.

The primary goal of the seminar is to propose a model that integrates safety and efficacy with compliance and more general program management needs. A secondary goal is to ensure elements of the product development process that are normally within the scope of a regulatory audit or inspection are distinct from elements that might not be of primary interest to regulators and notified bodies.

Learning Objectives:

  • Be aware of existing regulatory literature as applied to design controls globally
  • Understand design controls activities required by existing regulations, standards, and guidance
  • Understand the elements of a Quality Management System as distinct from a Business Management System
  • Understand the key elements of a product development process and how it goes beyond design controls
  • Apply product development process stage gates to both serialized and iterative development models
  • Effectively defend design controls in an audit or inspection without pulling out-of-scope product development activities into the discussion

Areas Covered :

  • An overview of existing regulatory literature as applied to design controls
  • A detailed walkthrough of design controls activities and deliverables required by existing regulations, standards, and guidance
  • The components of a Quality Management System and a Business Management System
  • The structure of a stage gate product development process
  • Mechanisms to advancing through stage gates
  • Application of a product development process to a serialized or v-model development approach
  • Application of a product development process to an iterative (e.g. Agile scrum, SAFe) development approach
  • Adapting the product development process to change management and post-production maintenance
  • Defending design controls when embedded in a product development process

In-Person Seminar going Virtual with increased learner satisfaction.

Yes, attend this seminar from anywhere. We are making it real and more interactive – Here's a sneak peek:

Our enhanced delivery process and technology provides you an immersive experience and will allow you to access:

  • The real-time and live presentation as in in-person events
  • Private chat for company-specific conversation – the same as you would get in an in-person seminar
  • Opportunities to connect with your peers to share knowledge at a different time and have group discussions
  • Live workshop activities
  • Live Q&A during the event and offline Q&A assistance after the event
  • As usual more content, activities and case studies and now adding homework for a comprehensive understanding
  • Certification

Who will Benefit:

  • Quality Assurance Staff, Managers, Directors, VPs
  • Regulatory Affairs Staff, Managers, Directors, VPs
  • IT Staff, Managers (including project managers), Directors, VPs
  • Manufacturing Managers, Directors, and VPs
  • Clinical Affairs Staff, Managers, Directors, and VPs
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

November 16th, 2021 (8:30 AM - 4:30 PM PST)

  • 8:30 AM - 8:59 AM: Registration & Meet & Greet / Introductions
  • 9:00 AM - 10:00 AM:
    • Training objectives review, expectations and scope.
    • Introduction to design controls
    • Walkthrough of design controls activities
  • 10:00 AM - 10:15 AM: Break
  • 10:15 AM - 12:00 PM:
    • Walkthrough of design controls activities (continued)
  • 12:00 PM - 1:00 PM: Lunch
  • 1:00 PM - 2:30 PM:
    • Introduction to the product development process
    • The Quality Management System (QMS) as a subset of the Business Management System (BMS)
    • Applying a stage gate product development process to serialized product development
  • 2:30 PM - 2:45 PM: Break
  • 2:45 PM - 4:30 PM:
    • Applying a stage gate product development process to iterative product development
    • The product development process and change management
    • Defending design controls within an overall product development process
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Eric Henry

Eric Henry
Senior Quality Systems and Compliance Advisor, King and Spalding LLP

Eric Henry is a Senior Quality Systems and Compliance Advisor in the FDA and Life Sciences practice of the law firm King & Spalding. Eric is a 30-year industry veteran having led and coached global organizations through a wide variety of quality and compliance challenges. Complementing his leadership experience is an extensive hands-on skillset including audit management and response, Quality System remediation, software quality (including cybersecurity and AI/ML), medical device design controls, risk management, and regulatory due diligence.<,p>

Prior to King & Spalding, Eric led global technical and quality functions at Philips, Medtronic, GE Healthcare, Boston Scientific, and Hologic.

Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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