ISPE Turkey GAMP Committe Workshop “Data Integrity Breaches, Data Mapping and Data Integrity Risk Assessment (DIRA)” 24 May 2024
  • ISPE Turkey GAMP Committee Workshop
    “Data Integrity Breaches, Data Mapping and Data Integrity Risk Assessment (DIRA)”
    24 May 2024 Friday, 09:00-12:00

    ISPE Turkey GAMP (Good Automated Manufacturing Practices) Committee will hold a meeting for sectoral information on Friday, May 24, 2024 between 09:00-12:00 at PharmaVision San. ve Tic. A.Ş., Topkapı Facility. In the session to be held, the topic "Data Integrity Breaches, Data Mapping and Data Integrity Risk Assessment (DIRA)" will be presented as a workshop by Güneş Hanağası, Quality Systems and Compliance Manager at Viatris İlaçları and Sanofi İlaç Validation Manager Banu Arat Erkan. Mr.

    As it is known, in parallel with technological developments and sectoral dynamics, data integrity has become a basic GxP requirement and regulators are giving priority to Data Integrity and Data Mapping issues by performing more inspections today than in the past. In addition, in this context, FDA requirements for data integrity, the MHRA Data Integrity Guide dated March 2018 and the WHO Annex 4 DI guide dated 2021 have been published, and DIRA issues are emphasized in a significant way in these guides. We hope to be together in our session where Data Integrity violations, Data mapping, approaches to Data Integrity Risk Assessment (DIRA) processes and the impact of all these on quality assurance processes will be discussed in detail.

    Date: 24 May 2024 – Friday
    Time: 09:00 - 12:00
    Location: PharmaVision San. ve Tic. A.Ş., Davutpaşa Cad. No: 145, Topkapı/İSTANBUL

    Who Should Participate?

    Employees, managers and managers of companies' Quality Assurance and Validation departments, as well as auditors who are responsible for the organization and execution of audit follow-up (inspections) in their companies, and employees from production and IT departments.

    Participation and Registration:

    The quota is limited to 50 people and participation is free for ISPE Members.

    Participation fee for non-member participants is 250 TL.

    The request of the first 50 people will be accepted and participation is limited to a maximum of 3 people from the same company.

    Session Language: Turkish