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Considerations & Steps for Building a Contamination Control Strategy (CCS)

 

Conventional approaches to Contamination Control are changing. They are being driven by the need to anticipate contamination events, rather than simply react to them; and new regulations are supporting this shift in thinking. Defining a Contamination Control Strategy (CCS) is unique for each process and requires an intimate understanding of both the process and how to implement an effective strategy. This presentation will go into depth on both topics.

  • Presenter

    Anna Campanella, PhD

    Advisory Team Head, Particle Measuring Systems

    Anna has vast industry experience which she uses to collaborate and consult with pharmaceutical companies. She is highly skilled in the development and implementation of science-based strategies, principles of contamination monitoring, and methods of controlling and improving the chemical, physical, and microbiological states of various production processes. Anna holds a PhD in Molecular Medicine and is an authority in many areas of pharmaceutical manufacturing; such as: QA & QC processes, validation of chemical and microbiological methods and the validation of sterile production processes. Additionally, she maintains expert-level knowledge of the microbiological aspects of aseptic production processes.

  • Presenter

    Sra Ugo Omeronye

    Especialista em Consultoria Farmacêutica Global

    Ugo trabalhou com empresas farmacêuticas para apoiar a garantia e o controle de qualidade. Ela é especialmente qualificada em ações corretivas e preventivas orientadas por dados para estratégias de monitoramento ambiental e controle de contaminação que afetam dispositivos médicos e produção de medicamentos. Ugo obteve seu mestrado em Ciências Biomédicas; com foco em farmacologia, metodologias de validação e tecnologias para agilizar efetivamente a fabricação estéril.