ISPE – Turkey Affiliate

ISPE Turkey Affiliate
“Readiness to the Sterile Production Facilities of the Future”
7 June 2018
Seminar Program

 

  08:30 - 09:00 Registration

  09:00 - 09:30

Opening Remarks
Fatma Taman / Chair of ISPE Turkey Affiliate

  09:30 - 10:15 Jean François Dulière / Chair of ISPE Commenting Group for Annex 1
EU GMP Annex 1 History, Reasons for revision, Scope and Principles

  10:15 - 10:45 Coffee Break

  10:45 - 11:30 Jean François Dulière / Chair of ISPE Commenting Group for Annex 1
Annex 1 Review (Chapters 3-6):
Quality Management, Personnel, Premises, Equipment

  11:30 - 12:00 ISPE Turkey Affiliate General Assembly Meeting

  12:00 - 13:00 Lunch Break

  13:00 - 13:30 Burcu Şeker / Ecolab Life Sciences Division Business Development Manager
The New Annex 1 and Contamination Control: Review and Likely Impact

  13:30 - 14:00 Coffee Break

  14:00 - 14:45 Jean François Dulière / Chair of ISPE Commenting Group for Annex 1
Annex 1 Review (Chapters 7-10):
Production and Specific Technologies, Environmental and Process Monitoring, Quality Control

  14:45 - 16:00 Panel: Q&A and Sectoral Evaluations
Panel Moderator:
Fatma Taman, Chair of ISPE Turkey Affiliate

English-Turkish / Turkish-English simultaneous translation will be provided.

Moderator:
Figen Ergin
ISPE Turkey Affiliate Board Member & Data Integrity Working Group Leader

Announcement | Seminar Program | Resumes (In Turkish) | Location

Affiliate of the Year Award

10 years