ISPE Turkey GAMP Committee Workshop

“IT Quality Assurance and IT Security for QA Departments”

Thursday, November 2, 2023, 09:00-12:30

For the purpose of sectoral information, the session to be held at Kavacık Park Inn Radisson Istanbul Asia Hotel between 09:00-12:30 on Thursday, November 2, 2023, by the ISPE Turkey GAMP (GoodAutomatedManufacturingPractices) Committee; and the topic "IT Quality Assurance and IT Security for QA Departments" will be presented as a workshop by Haluk Tanca, who provides consultancy services at ConvalGroup to the pharmaceutical industry in the field of Validation and IT Quality Management.

As it is known, ISPE GAMP® 5 2nd Edition, which was revised in parallel with technological developments and sector dynamics, was published in July 2022. With commen needs, the revision process has been initiated by EMA in the EU Annex 11: Computerised Systems guide and an announcement has been made regarding the scope of revision. In both GAMP® 5 and Annex-11 revisions, “IT Quality Assurance and IT Security” issues are emphasized in an important way. We hope to be together at the workshop where possible changes in IT processes and the impact of the new approach on validation and quality assurance processes will be discussed in detail.

Date: 2 November 2023 – Thursday

Time: 09:00-12:30

Location: Kavacık Park Inn Radisson Istanbul Asia Hotel Kavacık/BEYKOZ

Program:

09:00-09:10 Opening Speech

09:10-12:00 “IT Quality Assurance and IT Security for QA Departments” presentation

12:00-12:30Q&A and Sectoral Evaluations

Who Should Attend?:

Employees, managers and managers of companies' Quality Assurance, IT and validation departments

Participation and Registration:

The quota is limited to 50 people and participation is free of charge for ISPE Members. Participation fee for non-member participants is 250 TL and bank information for payment is shared below.

ISPE Türkiye Bank Account (TL)
ISPE – Sağlık Bilimleri Derneği
Yapı Kredi Bankası
İstanbul Topkapı-Davutpaşa Şubesi
IBAN: TR920006701000000095497755

Session Language: Turkish