Microsoft Gold Certified Partner

WEBINAR

IT Infrastructure Assurance - Life Science Industry

On 29 July 2020 Wednesday 11:00 AM EST

Watch Recording

Regulated organization increasing trend of dependency on a computerized system for GxP business operations are directly dependent upon underlying IT infrastructure. This certitude brings validation and quality operations related to IT infrastructure maintenance at the center of attention. In a regulated environment validated status of the GxP application is always depends on the assurance of underlying IT infrastructure. The consequence of IT infra quality operations failure can be significant. Based on the severity of risk entire region or site business operations can be at the halt or cease.


There is an acute need to bring IT infrastructure operations under organization quality operation standards by building good IT practices and through planned qualification program.


This webinar is planned to guide on good IT practices for regulated life science industries and for related supplier IT systems so that IT infrastructure maintenance in a demonstrable state of control and regulatory compliance can be obvious.

Speaker Introduction



Haluk Tanca
Senior Consultant IT & Validation, Convalgroup

Haluk is a result-oriented, highly motivated, success-driven professional with 30+ years of rich experience in IT and business operation in Pharmaceutical, FMCG, Service, Manufacturing, Food, Home appliance sector with multi-cultural and matrix organizations.
In Haluk’s past IT journey; he has worked closely with senior and line managers between business function and information technology providing them with expert guidance, support, and a full range of technology innovations.


Experiences

  • Senior Consultant IT & Validation – CONVALgroup
  • IT & Business Operations Consultant, Freelance
  • EMEA IT Associate Director, UCB Pharma
  • IT Coordinator (Emerging Markets) / IT Manager – Kodak (Near East) Inc.

What will you take away from the session?


  • Good Practices for Establishment of New platforms and for existing platforms supporting GxP operations
  • Structured approach, including Risk Management, to the qualification, management, and control of IT Infrastructure platforms supporting GxP applications
  • How to avoid unnecessary effort, by addressing a horizontal, or platform based, approach?