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    Resources

    On-Demand Webinars

    Learn from our experts the sterilization basics and advanced topics. Content designed to help you mitigate risk, go to market faster, and achieve excellence in your field.

    Product Adoption for Ethylene Oxide Sterilization

    Adoption of a new product into a device family or changes to the design and...

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    Manufacturing, and Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

    The biopharmaceutical sector has been changing very rapidly from monoclonal antibodies to cell and gene therapy...

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    Product Safety: Future State of Sterility Assurance and the Role of Terminal Sterilization

    Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained...

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    EO Sterilization: Considerations for Neonate Products and Medical Devices & ISO 10993-7

    EO sterilized items are life-saving and critical devices that are sterilized in highly regulated environment…

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    PQ dose mapping and routine irradiation of products with non-uniform density distribution

    Biotech drugs are the fastest growing segment of pharmaceutical and biotech pipelines...

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    Successfully execute a nitrogen dioxide (NO2) sterilization validation for a drug in a pre-filled syringe

    Biotech drugs are the fastest growing segment of pharmaceutical and biotech pipelines...

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    Cobalt-60: The Heart of Radiation Sterilization

    For more than 50 years, Cobalt-60 has been used as a source of gamma radiation…

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    Part 2: Validating, Optimizing and Monitoring EO Sterilization Processes

    Establishing an EO sterilization process can be a complicated path as multiple factors play a role in the design of...

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    Part 1: Validating, Optimizing and Monitoring EO Sterilization Processes

    Establishing an EO sterilization process can be a complicated path as multiple factors play a role in the design of...

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    Why is the sterility of your drug product much more than just a test of sterility?

    A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and...

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    Key Elements of a Sterility Assurance Program

    This presentation will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early…

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    Materials Qualification of Healthcare Products to Radiation Sterilization

    This webinar provides guidance for healthcare product manufacturers in qualifying the material used in products being sterilized with radiation.

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    A Review of Ionizing Radiation Sterilization Modalities

    This webinar will focus on a comparison of Gamma, Electron Beam, and X-Ray technologies to guide a manufacturer through this critical decision.

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    Establishing Maximum Acceptable Dose

    This presentation will focus on radiation interaction with materials and the proper design of experiments to establish a product’s maximum acceptable dose.

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    Process Definition – The Critical First Steps in the Validation of an EO Sterilization Process

    In this course, you will learn about the importance of process definition (fractional) work as a part of an EO validation and why it is not only important but required.

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    What is a sterilization dose audit and how are they performed?

    This presentation will focus on the purpose and activities associated with sterilization dose audits.

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    An Introduction to Radiation Dosimetry and the Mathematical Model

    This presentation will describe the benefits of parametric release and how best to establish a compliant and capable process design.

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    Regulatory Landscape for EO Residue Levels in Medical Devices

    The global regulatory landscape around Ethylene Oxide (EO) residues is a topic of increasing interest. This webinar will provide an overview of EO sterilization and the status of ISO standard...

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    Performance Qualification for Gamma Irradiators

    Sterilization validation is a critical phase in the life cycle of your sterile product.  This webinar will focus on the Performance Qualification (PQ) methods for Gamma irradiators which is the...

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