Fiona Lin

Head of Technical Documentation Department, A pharmaceutical equipment company

With over 10 years of technical documentation engineering experience in pharmaceutical equipment, I currently serve as a Technical Documentation Engineer at a pharmaceutical technology company and hold an MBA from Nanjing University. Specializing in compliance documentation system development and digital transformation, I excel at bridging technical, business, and regulatory needs. Proficient in international standards such as GMP and FDA 21 CFR Part 11, I am dedicated to advancing document management from traditional models to intelligent platforms.

All Sessions by Fiona Lin

  • May 22


  • TBD  - TBD
    The presentation will demonstrate how to establish an end-to-end digital validation process through deep integration of CMS (Content Management System) and OA (Office Automation) systems. Key components include business requirement analysis, system architecture design, test environment consistency verification, and process deviation management. It will also showcase the development of a standardized validation solution database, bilingual translation of core functionalities, and the final quality review approval for deployment.
    Regulation, Standards & Compliance for Exported Products




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Fiona Lin