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2020 ISPE Annual Meeting & Expo

2020 ISPE Annual Meeting & Expo

The 2020 ISPE Annual Meeting & Expo will focus on steering the future of pharmaceutical science and manufacturing toward a more global, synchronized, and quality-driven industry. This signature event draws pharmaceutical and biopharmaceutical professionals at all levels of the industry from young professionals to the most senior executives in drug manufacturing, supply chain, devices and equipment and services, and global regulatory agencies. 

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Guidance Documents

  • GAMP RDI Good Practice Guide: Data Integrity by Design

    GAMP RDI Good Practice Guide: Data Integrity by Design

    Published
    This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity.
  • Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

    Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

    Published
    Thisguide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.
  • Good Practice Guide: Critical Utilities GMP Compliance

    Good Practice Guide: Critical Utilities GMP Compliance

    Published
    The goal of the ISPE Good Practice Guide: Critical Utilities GMP Compliance – How to Be Compliant and Ready to Prove It is to help pharmaceutical organizations achieve and maintain their critical utility systems in a state of control, and then be able to efficiently demonstrate their systems’ Good Manufacturing Practice (GMP) compliance to regulatory inspectors and auditors.
  • Good Practice Guide: HVAC & Process Equipment Air Filters

    Good Practice Guide: HVAC & Process Equipment Air Filters

    Published
    The ISPE Good Practice Guide: HVAC and Process Equipment Air Filters aims to be a valuable reference on the selection, application, specification, testing, and operation and maintenance of filters in the pharmaceutical industry. This Guide is intended to be used as supplement to the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC), providing detailed information into the subject of air filters in HVAC and process equipment applications.
Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector, including varying potential demand for any given new therapy, evolving platforms and technology, questions...