Is it true, the European GMP Annex 1 revision will have no adverse impact on resources or costs while supporting new technology implementation?

Is it true, the European GMP Annex 1 revision will have no adverse impact on resources or costs while supporting new technology implementation?

03/21/2017, 10:30 AM - 11:15 AM

Meeting Room 4

Language:
English

The presentation goal is to answer the question (asked in the title) by deep diving into the impact on each revision proposed by several entities. The presentation will highlight the link between the different guidelines and how it will impact the Annex 1 revision. The presentation will explain the impact of the next revision on the field. In addition, I will present the gaps identified between the current practices and the future requirement of the annex 1 based on my global benchmark and the output of workshops. These workshops are led by the Belgium Industrial Pharmacist (UPIP VAPI) and is represented by more than 10 aseptic manufacturers. Finally, the presentation will finish with best practices observed from the field and other workshops.

Contributors

  • Walid El Azab

    Speaker

    Technical Service Manager

    STERIS Life Science

    Walid El Azab is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently provides technical support related...

Documents

Type of Session

  1. Type of Session
    Session

Learning Objectives

  1. Learning Objectives 1. At the end of the presentation the attendees will be able to understand: - The links between PIC/S, WHO, FDA, EU, JP guidance and ISO documents on contamination control and the revision of the Annex 1. 2. - The impact of the Annex 1 revision on the field 3. - The advantage of effective Risk assessment to design effective contamination control procedures and aseptic processes.

Categories

  1. Track
    Enabling Technologies to Streamline Operations

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