CLOUD Systems in GxP Processes and Validation

Description of the Seminar

Recently in pharmaceutical industry, Cloud Systems are being significantly preferred both in infrastructure and applications systems. This seminar guides you to understand the expectations of of Health Ministries (MoH, FDA, MHRA and EU) about cloud systems and cloud system validations. In this seminar, cloud system’s effect on computerized systems’ validation will be explained with ICH Q9 quality risk management approach.

Aim of the Seminar

Following terms about Cloud Systems will be explained in this seminar:

  • Systems’ Structure and Management
  • Regulations (FDA, EU, MHRA)
  • Relation between data criticality and data integrity
  • Ensuring data quality and integrity in the design stage of systems
  • Validation

Participant Profile

Agenda

09:00 – 09:30 : Registration
09:30 – 11:00 : Systems’ Structure and Management
11:00 – 11:30 : Break
11:30 – 13:00 : Regulations (FDA, EU, MHRA)
13:00 – 14:30 : Lunch
14:30 – 16:00 : Relation between data criticality and data integrity
16:00 – 16:30 : Break
16:30 – 17:30 : Cloud Systems’ Validation

 

Instructor

Timur Kabadayı MSc, MBA
Managing Director and Consultant of Conval Group Timur Kabadayı has nearly twenty six years of experience in pharmaceutical industry. Switching from being Maintenance Director of Eczacıbaşı Pharmaceuticals’ Lüleburgaz facility to Computerized Sytems’ Validation in Canadian corporation Apotex, he changed the course of his life and became Division Manager almost instantenously. In 2004, he founded Conval Group. With his team, he runs CSV projects domestic and international with success. Timur Kabadayı is a Certified Mechanical Engineer, he finished his MBA in York University, Toronto.

Seminar Location and Registration

Seminar Location: Conval Grup Egitim Salonu
Kanlıca Mah. Hacı Muhittin Sok. No:35 Beykoz İstanbul

Seminar Registration:

Registration Price: 400 EU + KDV (Included in Price: Seminar documents, seminar certificate, lunch and tea/treat supply for all day)

Contact:  Yağmur Tuğrul - 0549 203 0496
seminar@convalgroup.com

Payment Info 
Account Name: CONVAL GRUP VALİDASYON EGİTİMİ VE DANISMANLIK TİC. LTD. STİ.
Bank: AKBANK
Branch: Gayrettepe (287)
TL IBAN: TR11 0004 6002 8788 8000 0762 87
EUR IBAN: TR92 0004 6002 8703 6000 2088 48