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CO-LOCATED EVENTS

Speaker

Igor Dimitrievski

Manager of Service and Maintenance in Production PC Pharmacy, Alkaloid

Igor graduated in Electrical Engineering-Industrial Automation and Master of Science in Project management at FEEIT-Ss. Cyril and Methodius University in Skopje . He started his career as an engineer for the design and implementation of industrial automated systems and technical security solutions. Later, as a shift electrical engineer in pharmaceutical production, he actively participated in ensuring technical conditions in accordance with GMP regulations, as well as leading projects for the implementation and commissioning of new production equipment – blister and strip lines, dosing and packaging systems for liquid and semi-solid pharmaceutical forms, and the implementation of a Track & Trace (T&T) solution. In pursuit of greater efficiency and compliance, he designed and implemented a validated CMMS solution – AlkaMOS, fully compliant with GMP and ISO regulations, with modules for corrective and preventive maintenance, format change and tooling management, spare parts management,

calibrations and OEE, integrated with a higher-level system (MES). In his current role as manager of the service and maintenance department, Igor manages teams of experienced professionals, defines and monitors KPI indicators, optimizes production processes, designs primary and secondary pharmaceutical forms and packaging, resolves non-conformities, and plays a key role in preparation and presentation before regulatory bodies and audits.

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Session

Designing a CMMS for Pharma — Aligning Functionality with GMP-Driven Maintenance Needs

Case Study

Monday, September 22

03:00 pm - 03:25 pm

Live in Berlin

Less Details

This session will provide valuable insights into the design and implementation of a Computerized Maintenance Management System (CMMS) specifically tailored to meet the stringent requirements of pharmaceutical environments. Drawing from real-world system design experience, the presentation will demonstrate how a well-structured CMMS can seamlessly integrate corrective and preventive maintenance, manage tooling and size changeovers, monitor Overall Equipment Effectiveness (OEE), and optimize spare parts logistics—all while ensuring compliance with regulatory standards. Particular attention will be given to changeover and tooling management, highlighting strategies to improve efficiency and minimize downtime. In this session, you will learn how to: 

  • Integrate corrective and preventive maintenance workflows efficiently.
  • Manage tooling and format changeovers within a validated system.
  • Use CMMS data to drive OEE improvements.
  • Build a seamless link between spare parts management and maintenance planning.
Presentation

Company

Alkaloid

Alkaloid AD Skopje is a company which more than eight and a half decades, has been operating in the field of manufacturing drugs, cosmetic and chemical products and processing botanical raw materials. We keep investing in our dream of healthier life of each individual as we believe that THE HEALTH IS ABOVE ALL.
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Colocated with
Pharma Maintenance Europe 2025 is part of the Smart Manufacturing & Industry 4.0 Event Series. You can find more events here.
Date
September 22 – 23, 2025
Location
Maritim proArte Hotel
Friedrichstraße 151, Dorotheenstraße 65
10117 Berlin
Phone
+49 (0)30 52 10 70 3 0
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