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Monday, June 17 • 11:00am - 12:00pm
#108: Risk Management in Advanced Device Technology Development

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-522-L04-P; CME 1.00; RN 1.00

This panel will discuss innovative medical products due to their contribution to advancing medical care and are thus expected to have major impact in the coming years. Risk management pertaining to future technologies will be critical as product become more patient centric.

Learning Objectives

Analyze latest expectations and challenges utilizing an integrated risk management approach for combination products; Discuss the importance of an integrated risk management approach to increase product understanding earlier within the product development phase.

Chair

James Wabby, MHS

Speaker

Panelist
Kimberly Trautman, MS

Panelist
Donna Rycroft, BSN

Panelist
Olivia Wong, MBA


Speakers
avatar for Kimberly Trautman

Kimberly Trautman

Managing Director, Trautman International Services, United States
Experienced Medical Devices, IVD and Combination Product Expert with over 40 years of experience, including 24 years working at the U.S. FDA CDRH. Author of the 1996 Medical Device Quality System regulation and member of the authoring group for Combination Product GMPs in Part 4... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →
avatar for Donna Rycroft

Donna Rycroft

Director, Study Risk Management, AbbVie, United States
Strategic Leader in Clinical Development with 11 years expertise in Risk-based Quality Management (RBQM) leading the development, implementation and change management of RBQM models and supporting systems at AbbVie and Allergan. Currently leading a team of Study Risk Leads supporting... Read More →
avatar for Olivia Wong

Olivia Wong

Director, Quality, Combination Products, Gilead, United States
Olivia Wong is the Director of Quality, Combination Products at Gilead Sciences in Foster City, CA. She has 22 years of industry experience in medical devices and combination products, where she has provided quality engineering expertise throughout the product lifecycle, including... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum |   06: TranslationalDelivery Tech-PrecMedicine, Forum