2-Day Virtual Seminar

Design Control Essentials for Medical Devices

BY: Susanne Manz, President and Principal Consultant, Manz Consulting Inc.

Virtual Training Through WebEx
Various parts of the country are still battling the Coronavirus (COVID-19), we will conduct the class 100% online.

July 23-24, 2020
(10:00 AM to 3:00 PM EDT)
Virtual Seminar
  • Course Description
  • Agenda
  • Speaker
  • Price/Register

Design Controls are essential for producing safe and effective medical devices. Therefore, Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This 2-day virtual seminar will help you understand, develop, and implement design controls processes and tools that are a competitive strength for your company. You will learn how to incorporate design controls into your product development process to help streamline development and ensure quality and compliance.

In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for design controls and how to translate them into an efficient and effective process for your company. The seminar will cover the history, context, and requirements for design controls. Discussion will include requirements and tools in detail and include exercises to help you practice and improve your design control process.

Learning Objectives:

In this virtual seminar, students will understand the regulations, context, and history of design controls. They will learn how to use design control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference:

  • Expectations
  • Regulations and History
  • Design Control process, procedures, forms, records, files
  • Linkages to the rest of your Quality Management System
  • Lessons Learned
  • Myths
  • Challenges
  • Best Practices
  • FDA Inspection Readiness
Who will Benefit:
  • R&D Engineers
  • R&D Project Leaders
  • R&D Managers and Directors
  • Individuals participating in Product Design and Development
  • Individuals participating in design changes and failure investigations
  • Regulatory Affairs
  • Design Quality Engineers
  • R&D engineers and scientists
  • Compliance Specialists
  • Auditors
  • Senior Management
  • Anyone new to Design Control
Day 01(10:00 AM - 3:00 PM EDT)
  • 10.00 AM: Session Start
  • Session 1 (90 Mins):
    • Overview and Expectations
    • Background of FDA regulations
    • Design Controls as an integrated part of New Product Development
    • Design Planning
    • Project Management
  • Break
  • Session 2 (90 Mins):
    • Design Inputs
    • Design Outputs
    • Tools, forms, documents
  • Break
  • Session 3 (90 Mins):
    • Design Verification and Validation
      • Concepts
      • Strategies
      • Statistical techniques
Day 02(10:00 AM - 3:00 PM EDT)
  • Session 1 (90 Mins):
    • Design Review
    • Design History File
    • Documentation Requirements
  • Break
  • Session 2 (90 Mins):
    • Design Transfer
    • Design for manufacturability concepts
    • Design Changes
    • Change Control and configuration management
    • Linkages to other quality sub-systems
      • Risk Management
      • Failure Investigation
      • CAPA
  • Break
  • Session 3 (90 Mins):
    • Inspection Preparedness and Compliance Strategy
    • Lessons Learned
    • Myths
    • Challenges
    • Best Practices
Susanne Manz
Susanne Manz, President and Principal Consultant, Manz Consulting Inc.

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

Register Now

Online using Credit card

$1,899.00

(One Dial-in One Attendee)

July 23-24, 2020, Virtual Seminar

$9,685.00

Group-Max. 10 Attendees

July 23-24, 2020, Virtual Seminar


For discounts on multiple registrations, contact customer care at +1-888-771-6965.

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Terms & Conditions to Register for the Seminar/Conference/Event »

Terms & Conditions to register for the Seminar/Conference/Event

Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ customercare@grcseminars.com

Payment:
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

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