ISPE Istanbul University Faculty of Pharmacy Student Chapter

ISPE Turkey Seminars

28 March 2008 - GAMP 5

Guy Wingate - GlaxoSmithKline (GSK)

GAMP 5-Drivers, Objectives & Benefits

GAMP5, PAT & Qbd

David Selby / Selby Hope International Ltd.

The New GAMP 5

Validating Complex Computer Systems

14 September 2007 - ICH Q9-QUALITY RISK MANAGEMENT

Nigel Hamilton - Sanofi Aventis

Principles and Applications of ICH

Assessing Facilities Needs for the Manufacture of Pharmaceutical Prroducts Using a Risk Based Approach

Annemie Van Schoor - Pfizer

Design of an Event Handling System Based on a Quality System and Quality Risk Management Approach

Quality Risk Management for Contract Manufacturing

Assoc. Prof. Günal Günsav - G+P Projecktentwicklung GmbH

Quality Risk Management for Contract Manufacturing

Organized Studies by ISPE TURKEY

1.Getting - storing - stocking raw material

2.HVAC- filter systems- filters

3.Design of production areas

4.Design of production buildings

5.Warehousing

6.Process control(6 sigma)

7.Cost of production parts

8.Machines and mechanisms

9.Risk management

10.Content uniformity

11.Techniques for interview - pharm regulations (case study)