Our Services

Personnel & Training

We organize training programs to raise awareness of your staff on GMP principles and pharmaceutical manufacturing practices. Our trainings aim to improve the knowledge and skills of the staff by supporting them with theoretical and practical applications.

Personnel

  • Personnel Technical Evaluation
  • Team Set-up

Training

  • Sterile Manufacturing and Sterile Product R&D Processes
  • Isolator Technology and Operations; Sterile Manufacturing, High-Potency Products and Quality Use
  • Aseptic Filling Processes; FFS (Form Fill Seal), BFS (Blow Fill Seal), PFS (Pre-Filled Syringe), Cartridge, Ampoule, Vial Production Technologies
  • PUPSIT (Pre-Use Post-Sterilisation Integrity Testing) System Design and Applications
  • Qualification and Validation Applications in Equipment and Systems
  • Cleanroom Operation, Aseptic Techniques and Personnel Behaviour
  • Facility and Cleanroom Design Approach
  • Facility Critical Systems; HVAC, Water System, Infrastructure Systems, Operation and Design Approach
  • Sterilisation Techniques and Practical Applications
  • Aseptic Process Simulation (Media Fill) Design and Applications
  • Cleaning Validation
  • Process Validation
  • Contamination Control Strategy (sterile, solid, liquid, semi-solid forms)
  • FMEA Risk Analysis and Root Cause Analysis (with case studies) (Specific topics selected from all departments: Production, KG, Quality, Technical Services, Planning, Warehouse, Qualification-Validation-Calibration)
  • Process and Line Efficiency Approach, Cost-Effective Processes (sterile, solid, liquid, semi-solid forms / design, time, consumption, budget, materials, products, etc.)
  • GMP Training (Basic or Advanced Level)
  • Containment Technology & High Potency Product Operations
  • Qualification & Validation Applications for Machine & System, Ccleanroom

(… Specific training based on the request subject …)

personel & eğitim