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RA/QA: Answers to FDA and ISO Gray Areas

When: Wednesday, June 12 | 2:00 pm - 2:45 pm  
Where: Room 49 - Product Lifecylce Management Track
Level: All
Participant Types: Research & Development, Product Development, Quality Control, Regulatory/Clinical Affiars

 

Descriptions

Every day, people like you in companies everywhere are sidetracked by questions and scenarios that aren’t clearly explained in a regulation or standard. When this occurs, you need to decide what, if any, action to take. There is no roadmap, and the uncertainty and ambiguity cause confusion and delay for you and your team. Our panel of regulatory and quality experts has lived the “gray areas” and is excited to collect your questions and provide their recommendations for your optimal response.

Attendee Takeaways

  • Learn FDA and ISO gray areas that challenge your peers
  • Understand how regulatory and quality experts critically think through vague regulations and standards
  • Receive advice on how to respond to FDA and ISO questions

Speaker 

Jeff Tyber, President, CEO and Founder, Tyber Medical, has worked in the orthopedic industry for over 12 years in product development, research and management roles. Mr. Tyber was most recently the R&D Manager for Extremity Medical, where he and his product development group were responsible for the invention, development and release of 10+ products. Mr. Tyber previously served as a Design Engineer with B. Braun Aesculap in the spine division, and was a co-founder and Senior Engineer for Medshape Solutions. Mr. Tyber is a named inventor on over 39 domestic and international patents and patent applications. He graduated from the University of Colorado with an MS and BS in Mechanical Engineering.

Dawn Norman, Executive Vice President, MCR/X, has 20 years of experience in the medical device industry leading regulatory affairs, quality systems and clinical affairs in multiple start-ups and a major Fortune 500 company. Her experience spans Class I, II and III medical devices, combination, and tissue products, such as recombinant proteins for bone fusion, spine, orthopedic trauma, software, imaging technologies, electrophysiology and interventional devices, vascular access and dental technologies. She holds a BA and MS from Southern Illinois University at Edwardsville.

Kimberly Light has worked in the medical device industry for over 20 years in roles, ranging from product design and development to business development. For the past four years she has served as the Director of Regulatory Affairs at BioPro. During her career, Ms. Light has led multiple projects to design, implement and improve ISO 13485 compliant Quality Management Systems and processes and achieve and maintain regulatory compliance, including international licenses and product registrations. She has been involved in multiple device development projects from conceptualization through global product registration, sales and marketing support and training on a domestic and international level. She holds a bachelor's degree in bioengineering from Syracuse University and a bachelor's in biology from S.U.N.Y Fredonia.

Peter Mohn, Continuous Improvement Manager, Tyber Medical, has worked in the medical device industry for over 25 years in operations, product development and quality engineering management. His experience includes the design-of and design-transfer-of orthopedic implants (Stryker/Howmedica), as well as high speed automated fabrication of blood collection containment and acquisition devices (Becton Dickinson). He is a DMAIC Six Sigma Black Belt and Transactional Six Sigma Green Belt. He holds a BS in Electrical Engineering from the New Jersey Institute of Technology.

Check back for a bio on Amanda Tamburini, Lead Auditor, BEPC.