Training

Training

We conduct Custom Trainings depending on customer needs to employees at all levels who are engaged in the manufacture / storage / distribution of Pharmaceutical / Cosmetics / Medical devices / Dietary Supplementary Products.

Basic GMP Training

  • Quality Management and Pharmaceutical Quality System
  • Sanitation and Hygiene
  • Documentation Part one
  • Documentation part two
  • SOP Technical Writing
  • Data Integrity
  • Personnel
  • Premises
  • Equipment
  • Materials
  • Complaints and Recalls
  • Contract Production, Analysis and Other Activities
  • Self Inspection and Quality Audit
  • Good Practices in Production and Quality Control
  • Quality Risk Management
  • Good Distribution / Warehouse Practice

Quality control Laboratory

  • Good Practices for Quality Control Laboratories – Part 1: Management and infrastructure
  • Good Practices for Quality Control Laboratories – Part 2: Materials, equipment, instruments and other devices
  • Good Practices for Quality Control Laboratories – Part 3: Working procedures and safety

Microbiological Laboratory

  • WHO Good Practices for Pharmaceutical Microbiology Laboratories – Part 1
  • WHO Good Practices for Pharmaceutical Microbiology Laboratories – Part 2

GMP Inspection Process (Audit Training)

  • Role of the Inspector
  • Preparation for an Inspection
  • Types of GMP Inspections
  • The Inspection

Validation

  • Validation (Part 1): General overview on qualification and validation
  • Validation (Part 2): Qualification of HVAC & water systems
  • Validation (Part 3): Cleaning validation
  • Validation (Part 4): Analytical method validation
  • Validation (Part 5): Computerized system validation
  • Validation (Part 6): Qualification of systems & equipment
  • Validation (Part 7): Non sterile product process validation

Air Handling System

  • Heating, Ventilation and Air Conditioning (HVAC) – Part 1: Introduction and overview
  • Heating, Ventilation and Air Conditioning (HVAC) – Part 2: Air flows, Pressure concepts
  • Heating, Ventilation and Air Conditioning (HVAC) – Part 3: HVAC systems and components
  • Heating, Ventilation and Air Conditioning (HVAC) – Part 4: Commissioning, qualification and maintenance

Pharmaceutical Water

  • Water for Pharmaceutical Use – Part 1: Introduction and treatment
  • Water for Pharmaceutical Use – Part 2: Water purification, storage and distribution
  • Water for Pharmaceutical Use – Part 3: Operational considerations
  • Water for Pharmaceutical Use – Part 4: Inspection of water purification systems

Sterile Pharmaceutical Products

    • GMP for Sterile Pharmaceutical Products – Part 1

    General aspects in the production of sterile products, requirements for premises, area classification and touch on quality control aspects

    • GMP for Sterile Pharmaceutical Products – Part 2

    Requirements relating to personnel and equipment

    • GMP for Sterile Pharmaceutical Products – Part 3

    Different methods of sterilization, specific approaches in barrier technology, blow/fill/seal technology and quality control

    • Media Fill

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