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) | ||
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Registration Process: 8:30 AM – 9:00 AM Session Start Time: 9:00 AM
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Meet Your Instructor
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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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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 @ +1-888-717-2436 or email us @ [email protected]
Payment:
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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 $200 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 ($200) will be transferred to any future ComplianceOnline 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.
In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
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Testimonials
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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