Features
With the publication of recent guidance, specifically the US FDA Quality Systems Approach to Pharmaceutical cGMP Regulations1
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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Technical
The process life-cycle model, as discussed in the US FDA guidance on process validation, is a significant change in how we view validation.1