About

Elaine Vong is an experienced technical professional with over 15 years in the Medical Device and Pharmaceutical industries.  She is adept at assessing compliance state, identifying gaps, and implementing solutions. Elaine also possesses a keen ability to lead teams, problem solve and drive for results in matrixed environments.

 

Elaine had 14 years of experience with Abbott Laboratories, Diagnostics Division, where she held positions in Process Engineering, Process Validation, Qualification Engineering, and Compliance project management. Her consulting experience includes Compliance project management in the speciality Fine Chemical, In Vitro Diagnostics, novel Pharmaceutical and Injectable manufacturing.

She has managed Process Validation teams, Qualification departments, Compliance initiatives, Capital and CAPA projects.  Her expertise includes compliance project management (improvement projects, CAPAs, Quality by Design, etc.), Process Engineering, Facilities/Utilities/Equipment/Software Validation and Qualification, regulatory submission support and validation quality.

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