Yik Kit (Grace) Kwok

Company: Merck & Co

Job title: Senior Principal Scientist - Device Strategy & Operational Excellence

Bio:

Yik Kit (Grace) Kwok has over 20 years of experience in pharmaceutical device and combination product development. Her areas of expertise include project management, design controls, test method development/validation, risk management, design/technology transfer with working experience in devices including syringe, auto-injector, pen injector, MDI, DPI, applicators, and implants. Grace also has in-depth knowledge with 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and she led the combination product retrospective compliance project as well as the QMS redesign of the medical device and combination product quality system at Merck. Grace holds a Bachelor of Science in Applied Science Engineering and an MBA in Supply Chain and Entrepreneurship from Rutgers University.

Seminars:

Proactive Risk Management Strategies for Safe & User-Centric Combination Products 4:30 pm

Collaborating across companies, vendors, and cross-functional teams to develop a combination product risk management strategy Sharing best practices for risk management to enable patient-centric design Identifying potential design hazards early to minimize safety risks and improve product usabilityRead more

day: Conference Day One