Boston Chapter In Person Event: 2026 Risks with Pharmaceutical & Medical Devices in the Supply Chain

John Gawlak

Technical Manager/Senior Auditor, SGS

Over 35 years of Quality and Project Management Experience with over 29 years of Leadership Experience in the Pharmaceutical, Cosmetic, Personal Care, Food, and Medical Device Industry

Specialties: QA, QC, Supplier Qualification and Management, CMC, Quality Management, Project Management, Certification Auditing, Vendor Auditing, Internal Auditing, Analytical Testing, QC Laboratory Management

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Mingxiang Xu

Technical Director, Product Assessor Medical Devices, SGS North America

Mingxiang (Ming) Xu began his professional journey over 31 years ago, building on a multidisciplinary foundation in science, engineering, and business. His career spans a diverse range of industries, including scientific research, electronic manufacturing, information technology, alternative energy, and medical devices.

Ming currently serves as Technical Director at SGS North America, where he supports clients in meeting the requirements of the EU MDR, MDD, and UK MDR. A prolific reviewer of both active (including software) and non-active medical devices, he works across Class lla to Class III product categories. He is also recognized as a subject matter expert in devices without an intended medical purpose (Annex XVI) and drug-device combination products (Article 117).

Earlier in his R&D career, Ming contributed to the development of medical devices such as infusion systems, electrosurgical units, and endoscopic imaging technologies. His broader technical expertise also includes ultrasonic imaging, electromagnetic navigation, irreversible electroporation, ultrasonic surgical instruments, surgical robotics, electrohydraulic lithotripsy systems, endoscopic balloon catheters, introducers, guidewires, tissue acquisition and apposition tools, and sealing solutions. He holds multiple U.S. patents, most of which relate to innovations in medical technology.

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Dr Dujuan Lu

Head of Extractables and Leachables, SGS

Dr. Dujuan Lu serves as the head of the extractables and leachables (E&L) team at the SGS since 2015. Prior to joining SGS, she worked at Fresenius Kabi as a research scientist, leading E&L projects to support transfusion and infusion medical device and parenteral products in 2011-2015. She has 15 years of CRO and pharmaceutical/medical device industry experience with more than 1000 E&L projects on a broad range of packaging systems, including process materials, pharmaceutical finished packaging, and medical devices. As a subject matter expert in the E&L field, she is frequently presenting at various conferences as invited speakers, technical session chairs and short course instructors. She was named one of the top 60 most influential people working in the pharmaceutical industry in the Medicine Maker’s 2020 power list. Dr. Lu obtained her PhD in analytical chemistry from the University of Pittsburgh and BS in chemistry from Nanjing University.

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Gonda Lamberink

VP of Digital Trust, SGS

Gonda Lamberink is a digital trust leader with a career spanning GTM strategy, business development, and M&A across AI and cybersecurity assurance. She’s currently leading SGS’s Digital Trust portfolio and organization for North America. Prior to SGS she designed and implemented AI governance controls at the UN Joint Staff Pension Fund. She previously led Cyber Security M&A for Bureau Veritas, built commercial momentum at two cybersecurity SaaS companies (Cybeats and Fortress Information Security), and spent nearly nine years at UL advancing cybersecurity for IoT and industrial ecosystems. Her work has focused on IoT and product security, software supply chain risk management, and the development of regulatory‑aligned, industry‑driven TIC solutions (including process and management system certification frameworks) that help organizations build trust in their digital technologies.

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