Elizabeth Rivera

Johnson & Johnson
QA Validation Specialist
Elizabeth Rivera is Quality Assurance Validation Specialist III at J&J Consumer Health. Until recently, she was a Technical Service Manager for the Scientific Division of STERIS Corporation (Mentor, Ohio). She lectured on educational technical forums such as IPA, Interphex, ExpoFYBI, ETIF, PDA, ISPE, Expofarma, OMICS, Executive Conference, and more. She has published articles related to cleaning and microbial control. She has a bachelors and masters degree in Chemical Engineering from the University of Puerto Rico. Elizabeth has 20 years of experience and traveled to places in North America, Latin America and Europe to support companies in various aspects of cleaning and decontamination.

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Figure 1: Traditional cleaning validation approach emphasizes validating the cleaning process.
Technical
Cleaning Validation Program Maintenance in a Process Life-Cycle Model

The process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.US Food and Drug Administration. “Guidance for Industry. Process Validation: General Principles and Practices.” January 2011.