IT Processes and GxP Compliance Training

Globally, in the banking, energy and finance sectors, IT Processes are managed by ISO 27001, COBIT, ITIL. ITIL is mostly preferred application due to its flexibility and convenience among different sectors.. ITIL is also convenient for pharmaceutical industry because of its flexible structure and adaptability to regulations. In this seminar, guidances that ensure compatibility of IT processes in pharmaceutical industry such as GAMP5, Annex 11, 21 CFR Part 11 and MHRA (Data Integrity) will be explained as well as processes like periodic revisions, state of emergency management, business continuity and supplier management. In that way, usage of ITIL processes in IT processes in pharmaceutical industry will be ensured to use rather than GxP rules.
• Defining ITIL Processes
• Periodic Review Process
• State of Emergency Process
• Business Continuity Process
• Supplier Management Process
• How processes above should be defined under FDA, EU Annex 11 and ITIL requirements will be explained