ISPE Turkiye GAMP Committee Workshop “Audit Trail Review & Data Integrity Risk Assessment (DIRA)” April 4, 2024
  • ISPE Turkiye GAMP Committee Workshop
    “Audit Trail Review & Data Integrity Risk Assessment (DIRA)”
    April 4, 2024 Thursday, 09:00-12:30


    At the session to be held by the ISPE Turkey GAMP (Good Automated Manufacturing Practices) Committee for sectoral information on Thursday, April 4, 2024, between 09:00-12:30 at Abdi İbrahim İlaç Sanayi, Esenyurt Facility. The topic "Audit Trail Review & Data Integrity Risk Assessment (DIRA)" will be presented as a workshop by Figen Yılmaz Eğitim ve Danışmanlık Ltd. Mr. Şti. General Manager Figen Yılmaz and her teammates Seçil Evren and Begüm Doğramacı.

    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 Audit Trail Review issues by carrying out more audits 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 Audit Trail Review and DIRA issues are emphasized in these guides. We hope to be together at the Workshop to be held, where the approaches to Audit Trail Review & Data Integrity Risk Assessment (DIRA) processes, the importance of Audit Trail and DIRA processes, and the impact of all these on quality assurance processes will be discussed in detail.

    Date: April 4, 2024 – Thursday
    Time: 09:00 - 12:30
    Location: Abdi İbrahim Pharmaceutical Factory Hadımköy / ESENYURT

    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

  • Program:
    09:00 - 09:20: Opening remarks
    09:20 - 12:00:  “Audit Trail Review & Data Integrity Risk Assessment (DIRA)” presentation
    12:00 - 12:30: Questions - Answers and Sectoral Evaluations