Design Controls - A Roadmap to Successful Implementation
Rebecca Ellis, Vice President, RA/QA at Argon Medical
Coming soon.. Please contact customer care for new schedule
|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
- Design Controls: Historical Overview
- The World before the QSR
- Pre 1976 – Genesis of Medical Devices
- The FDA Recall Experience
- The Global approach
- ISO 9001
- GHTF and 21 CFR 820.30
- Basic Design Control Concepts
- What are Design Controls?
- Benefits of Design Controls
- Design Controls are Forever
- Approaches to Design Controls
- Differences and Similarities between Project Management and Design Controls
- Regulatory Elements, Helpful Quality Tools and Their Application
- Design and Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification
- Design Validation
- Design Transfer
- Design Changes
- Design History File
- Putting it All Together
- Integrating Design Controls and Project Management
- Life after Launch: Handling Design Changes
- The World of Post-Market Surveillance
- Risk Management and the Total Life Cycle
- Organizational Knowledge Management
- Looking to the Future
- FDA Views on the Current “Product Quality” Landscap
- Changing Expectations in the Global Economy
Meet Your Instructor
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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