Course Description:

Design Controls are a key requirement in both the FDA’s Quality System Regulation and ISO 13485:2003. Yet fifteen years after the introduction, it is still an opportunity for improvement for many companies. In the 2011 report on Understanding Barriers to Medical Device Quality, FDA stated that an ineffective Design Controls program was the root cause for 31% of the recalls for the period 2003 -2009. In spite of the resources dedicated to this effort, many companies struggle with translating customer requirements into the “critical-to-quality” parameters needed to design and validate their products and next-generation models.

The upcoming training program is an interactive workshop that reviews the origins of design controls, the regulatory requirements, with a brief review of useful quality and project management tools. This program includes time for interactive case studies to help the participants learn how to create, sustain and improve the design control processes for their organization, and provides a current “state of the union” to help identify future opportunities and challenges.

Learning Objectives:

Key goals of the conference will include learning:

  • Historical context that created the requirements for Design Controls for medical device manufacturers
  • Basic concepts of approaches to Design Control and how to drive the development cycle
  • The softer side of Design Controls – utilizing Project Management skills in a Regulated World – key document requirements and key differences
  • The Regulatory Landscape: the requirements and expectations of 21 CFR 820.30 and ISO 13485:2003 and nuances to look for
  • Interactive sessions/case studies for application of the elements
  • Warning Letter examples of how “not” to do it
  • The business reality of design changes and how to manage the information flow
  • How the product clinical experience impacts the Design History File
  • Risk Management considerations and FDA’s Total Life Cycle Approach
  • Practical challenges on knowledge management – organizing for success and speed
  • The changing regulatory landscape – current performance versus future expectations

Who will Benefit:

This course is designed for individuals involved in new product development and/or sustaining engineering projects who need to understand the regulatory framework for improving post-market success.

  • R&D Managers
  • Engineering Managers
  • RA/QA Managers
  • Team Members/Engineers/Specialists who provide support for Product Development/Change Activity
  • Sales and Marketing personnel
  • Product/Project/Program Managers
  • Compliance personnel
  • Auditors

Course Outline:

Day One: (8:30 AM - 4:30 PM)     Day Two: (8:30 AM - 1:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Design Controls: Historical Overview
    1. The World before the QSR
      1. Pre 1976 – Genesis of Medical Devices
      2. The FDA Recall Experience
      3. The Global approach
        1. ISO 9001
        2. GHTF and 21 CFR 820.30
    2. Basic Design Control Concepts
      1. What are Design Controls?
      2. Benefits of Design Controls
      3. Design Controls are Forever
      4. Approaches to Design Controls
      5. Differences and Similarities between Project Management and Design Controls
  2. Regulatory Elements, Helpful Quality Tools and Their Application
    1. Design and Development Planning
    2. Design Input
    3. Design Output
    4. Design Review
    5. Design Verification
    6. Design Validation
    7. Design Transfer

  1. Design Changes
  2. Design History File
  1. Putting it All Together
    1. Integrating Design Controls and Project Management
    2. Life after Launch: Handling Design Changes
    3. The World of Post-Market Surveillance
    4. Risk Management and the Total Life Cycle
    5. Organizational Knowledge Management
  2. Looking to the Future
    1. FDA Views on the Current “Product Quality” Landscap
    2. Changing Expectations in the Global Economy

Meet Your Instructor

Rebecca Ellis
Vice President RA/QA, Argon Medical

Rebecca Ellis currently serves as Vice President, RA/QA for Argon Medical Devices. She has a B.S. in Microbiology and an MBA in Operations Management from the University of Minnesota, and a Master’s Certificate in Organizational Leadership from Villanova University. Ms. Ellis has over 25 years of FDA-related experience in pharmaceuticals and medical devices, from concept, through design, development, submission and post-market compliance, and has managed teams of Quality Engineers who support the new product development process. Past work experiences include positions at Medical Incorporated, St. Jude Medical, International Isotopes, NeoRx, Colgate Oral Pharmaceuticals and OsteoMed. She is past Chair of the Dallas Section of ASQ, past Chair of the DFW Biomedical Discussion Group for the ASQ Biomedical Division, and past chair of the Lean Six Sigma SIG. In addition to her experience in medical devices and pharmaceuticals, Ms. Ellis has also participated as an Examiner for Quality Texas. Ms. Ellis holds various certifications from ASQ and RAPS, including CQA, CQIA, CQE, CQMgr/OE, CSSGB and RAC. She is a past co-instructor with AAMI and FDA for AAMI Quality Systems, been a RAPS co-instructor on Device Registrations and Quality Systems, and presented at numerous other industry events (ASQ, ASAIO, FMDIC).

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What past attendees say:

“The presenter was very good and it was a very comprehensive and excellent seminar.”
- Sr. Project Manager, NAMSA

“This event was educational and topic design control process was highly informative.”
- Regulatory Affairs Specialist, Bard Access Systems

“Rebecca Ellis is an excellent presenter with good people skills. SOPs reviewed during the presentation were excellent because knowledge not easily compiled from web was included in SOPs.”
- V.P. Research, Enteroptyx

“Topic 21 CFR 820 vs. ISO 13485 comparison for the design control elements were highly informative and valuable.”
- Quality Manager , Kimberly-Clark

“Elements dealing with planning business processes was extremely helpful because for me setting the team up for success is paramount.“
- R&E Sr. Specialist, Kimberly-Clark

“Design history file topic was highly beneficial for me as it is applicable to my job.”
- R&D Project Coordinator, Covidien

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