Computer Software Validation in GMP regulated environments

    We are pleased to invite you to Medicon Valley Alliance’s Good Morning Meeting on the theme Computer Software Validation in GMP regulated environments
    – An overview of non-compliance issues and a checklist for Computer Software Validation. A combined FDA and EudraLex approach

    Quality management of computer systems (hardware and software) is a central part of the overall quality management system in the pharmaceutical industry. In addition, quality management of electronic signatures and electronic records (i.e., data generated by computer systems) is also part of the overall quality management system. Computer systems must comply with cGMP requirements, when used in these regulated environments. As continuous technology advancements, cloud computing, virtualized process control systems and manufacturing networks, including security, converge into a technology-driven, ever-adapting industry, so does the potential risk of non-compliance with both internal instructions as well as regulatory governance.

    Date: February 4, 2015
    Time: 8:30 – 10:00
    Address: Arne Jacobsens Allé 15, 2300 Copenhagen S
    Room: Oslo/Bergen

    Participation

    For members: Free of charge (late cancellation*/no-show fee DKK 500 ex VAT)
    For non-members: Free of charge (late cancellation*/no-show fee DKK 500 ex VAT)
    (please see our event policy for non-members participation)

    Registration ends January 29th, 2015.
    * If you cancel after the registration ends, it is considered late cancellation.

    Program

    08.30-09.00  Coffee and networking
    09.00-10.00  Computer Software Validation in GMP regulated environments
    – An overview of non-compliance issues and a checklist for Computer Software Validation. A combined FDA and EudraLex approach

    This Good Morning Meeting is in collaboration with Genau & More

    GM