Nicole Granda Alvarez

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Alcon R&D Laboratories
Principal Engineer
Nicole Granda Alvarez is a Principal Engineer for extra-ocular devices in the chemistry and materials group of Alcon R&D Laboratories. She holds a bachelor’s degree in environmental design and a master’s degree in architecture from the University of Puerto Rico. Nicole has over a decade of experience in the regulatory industry in process engineering, quality, and validation with companies including Allergan, Johnson & Johnson, Abbott, Novartis, and Bristol Myers Squibb. She has experience as an architectural designer and LEED-accredited professional, and has volunteered in nonprofit organizations such as the US Green Building Council (USGBC) and ISPE.

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Figure 1: Cleaning recipe process map.
Technical
Life-Cycle Approach to Cleaning Topical Drug Products

Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation.1

  • 1US Food and Drug Administration. US Code Title 21: Food...