Monick Bassi de Paula Instituto Butantan

Monick Bassi de Paula has over 15 years of experience in the pharmaceutical industry, specializing in quality assurance, validation, and aseptic manufacturing. She has led the successful implementation of Annex 1 - PIC/S standards, ensuring compliance with international regulatory requirements for aseptic processes. Monick played a key role in the WHO pre-qualification for the influenza vaccine, where she designed and implemented a Contamination Control Strategy (CCS) and optimized aseptic processes. She also oversaw the qualification of the RABS filling line for the dengue vaccine and contributed to the aseptic production of the COVID-19 vaccine, focusing on process qualification and personnel training. Her expertise spans vaccines, biotechnology, oncology products, and biosimilars. As co-chair of PDA Brazil, she is an active industry speaker, regularly participating in events on aseptic personnel qualification, Annex 1 compliance, and aseptic processing standards.