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Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
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Learning Level: Intermediate
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Student Focus

Chang-Hong Whitney, RAC, MBA

President & CEO
Whitney Consulting Ltd.
Boston, Massachusetts

Ms. Whitney has over 30 years of experience in the medical device industry in both China and the United States. She founded Whitney Consulting Ltd. in 1994, specializing in Chinese regulatory affairs and compliance, serving primarily international clients.

With offices in Beijing and Boston, Whitney Consulting provides expertise in China regulatory strategy, product registration, post-market compliance, clinical affairs & management, quality system consulting, audits, and customized market research. The firm serves medical device companies worldwide, including several Fortune 500 clients.

As presenter or member of conference organization committees, Ms. Whitney has participated in many professional conferences, including Regulatory Affairs Professionals Society (RAPS) annual conferences, workshops and other industry organizations. Whitney Consulting also collaborates with the U.S. Commercial Service, the Canadian Trade Commissioner Service, and other national trade development organizations to provide guidance on Chinese regulations.

Ms. Whitney holds an MBA from Babson College and undergraduate degrees in electrical engineering and international business. She is a certified Regulatory Affairs Professional (RAC) and a member of RAPS. Additionally, she was an inaugural member of the RAPS Global Scope (GS) Exam Committee, serving for three years.

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