Paige Kane, PhD, CPIP

Paige Kane, PhD, CPIP

Greater Philadelphia
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Education

Licenses & Certifications

  • Certified Pharmaceutical Industry Professional (CPIP)

    ISPE Professional Certification Commission

    Issued

Volunteer Experience

  • ISPE Graphic

    Pharma 4.0 Advisory Board member

    ISPE

    - Present 2 years 1 month

    Member of the ISPE Pharma 4.0 Advisory Board that oversees all ISPE Pharma 4.0 workgroups

  • ISPE Graphic

    Author/contributor: ISPE Guidance Documents

    ISPE

    - Present 19 years 9 months

    GAMP Guides:
    Electronic Records & Electronic Signatures: 2005
    GAMP 5: 2008
    Data Integrity by Design: 2020
    GAMP 5 2nd edition: 2022
    Co- Lead & contributing author - ISPE Knowledge Management Good Practice Guide: 2021

Publications

  • 13 – Knowledge Excellence in the Lab: How Knowledge Management can enhance lab performance. Authors: Martin Lipa/Paige Kane/Anne Greene.

    Quality Control Lab. A Crucial Contributor to Pharmaceutical Value Creation and Quality System Performance. Edited by T. Friedli/S. Köhler/N. Calnan

  • Advancing Knowledge Management (KM) as an ICH Q10 Enabler in the Biopharmaceutical Industry

    Dublin: TU Dublin Academic Press

    This monograph is a publication of original research focused on biopharmaceutical sector Knowledge
    Management (KM) methodologies and capabilities. The authors, through their research, have developed
    models, tools and processes which can assist the sector gain greater clarity of the value and merits that KM can offer to organisations.

    Kane’s research was driven by a determination to close the gap from KM theory to practice.
    Her research addresses a void of research in, and…

    This monograph is a publication of original research focused on biopharmaceutical sector Knowledge
    Management (KM) methodologies and capabilities. The authors, through their research, have developed
    models, tools and processes which can assist the sector gain greater clarity of the value and merits that KM can offer to organisations.

    Kane’s research was driven by a determination to close the gap from KM theory to practice.
    Her research addresses a void of research in, and understanding of, the concept of KM in the biopharma
    sector, and proposes a foundational Pharma KM Blueprint (Kane 2018). The Pharma KM Blueprint illustrates holistic integration of core KM principles, models and tools to deliver real benefits to the patients and the business.

    Other authors
    See publication
  • A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

    CRC Press

    This book addresses the rapidly emerging field of Knowledge Management in the biopharmaceutical industry. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides multiple case studies and good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

    Other authors
    See publication

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