Alicia Tébar

QbD Pharmaceutical Services SL
Founder. QbD & GMP Consultant
Alicia Tébar is a chemist and a Six Sigma Black Belt with more than 20 years of professional experience in the pharmaceutical industry as QC and R&D manager in several multinational companies. Currently she is General Manager and Founder of QbD Pharmaceutical Services SL, a consultancy company based in Barcelona that assists clients in GxP- and QbD-related projects. As a trainer, she lectures on QbD at Barcelona University as a statistics postgrad-uate and at ESAME as a Pharmaceutical Industry Master. Alicia has been an ISPE member since 2011 and is a Co-Chair of the ISPE Pharma 4.0™ Special Interest Group’s Spanish working group.

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Reimagining CPV for a Pharma 4.0™ World
Features
Reimagining CPV for a Pharma 4.0™ World

The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV).1

  • 1US Food and Drug Administration Center for Drug Evaluation...