ISPE Turkey Affiliate Workshop
“Medical Device Regulation (MDR)” and “Continuous Process Verification (CPV) Requirements”
23 March 2023 Thursday, 13:00-16:00
The Workshop to be held on Thursday, March 23, 2023 between 13:00 - 16:00 by ISPE Turkey for knowledge share within pharmaceutical industry, “Medical Device Regulation (MDR)” topic will be presented by Bayer Türkiye Regulatory Affairs Manager Turkey&Iran- Radiology EMEA, Seda Uzun Doyduk and
“Continuous Process Verification (CPV) Requirements” topic will be presented by FYED General Manager Figen Yılmaz.
The following topics will be covered in the workshop;
ü Medical Device Regulation (MDR)
ü Guidelines and authority expectations on Continuous Process Verification
ü Continuous Process Verification lifecycle phases (Phase 1, Phase 2 and Phase 3)
ü CPV approach requirements for New and Existing products
We hope to be together in our workshop where the participants will learn about the Medical Device Regulation (MDR) and Continuous Process Verification (CPV) requirements.
Our workshop, which will be held face to face, is open to the participation of the whole sector, there is a registration requirement; ISPE members are given priority. In order to participate, a written notification must be made to [email protected].
Date : 23 March 2023, Thursday
Time : 13:00-16:00
Location: Bayer Türk Kimya San. Ltd. Şti.
Fatih Sultan Mehmet Mah. Balkan Cad. No:53 34771 Ümraniye / İSTANBUL
13:00-13:15 Opening remarks
13:15-14:15 “Medical Device Regulation (MDR)” presentation
14:15-14:45 Coffee Break
14:45-15:45 “Continuous Process Verification (CPV) Requirements” presentation
15:45-16:00 Q &A and Discussion