The Swiss Consulting

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TRAININGS

GMP – Trainings on Good Manufacturing Practices Quality Systems

  • Calibration and Modern Calibration Management
  • Cleaning Validation
  • Corrective and Preventive Actions Training (CAPA)
  • GMP – Good Manufacturing Practices Update Training
  • GMP documentation
  • Impurity and Degratation Training
  • Out- of- Specification (OOS)
  • Process Validation Training – Risk Based Approach
  • Process Validation, Quality By Design, Design Of Experiments
  • Product Quality Review (PQR)
  • Product Quality Review (PQR)
  • Qualification Training – Risk based Approach
  • Risk Management and Risk Analysis Techniques Practical Training (FMEA, FTA, ISHIKAWA, Filtration techniques)
  • Site Master File (SMF)
  • Stability Testing & Photo Stability Testing
  • Training on Change Control (CC)
  • Training on Computerized System Validation (Risk Based)
  • Training on Standard Operating Procedures (SOP)
  • Training on Validation Master Plan - VMP
  • User Requirements Specification (URS)

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    Other Trainings on Quality Systems

  • ISO 13485 – Quality Management Systems for Medical Devices
  • ISO 17020 – General Terms for Operating Different Type Examination Entities
  • ISO 17025 – General Terms for Experimental and Calibration Laboratories Qualification
  • ISO 9001:2000, ISO 9001:2008
  • MDD 93/42/EEC – Medical Devices Directive

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    GLP-Good Laboratory Certificate Programs

  • Analytic Method Validation (in compliance with EMA, FDA and ICH Rules)
  • GC/MS– Gas Chromatography & Mass Spectrometry and Practical Method Development Training
  • HPLC-Practical Method Development Training

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