Training

Pharma Solutions Ltd organizes GMP in-house training courses and GMP webinars.
The effectiveness of training is ensured by our highly professional trainers. The entire process is harmoniously integrated into the existing QMS of the plant.
All trainers are highly qualified practitioners.

Training services include:

  • Preparing a training program
  • Conducting a training in accordance with the developed program
  • Evaluation efficiency of a training

Our specialists conduct seminars and training on the following topics:

Quality Assurance

 Implementation of the process approach

 Pharmaceutical Quality System

 Changes Management System

 Deviation management system

Annual product quality review

 Risk management for the quality of medicines

 Personnel management system in accordance with GMP requirements

 Documentation management system

 Self-inspection

 Preparation for GMP inspection

Process equipment

 General requirements to process equipment

 Equipment for sterile manufacturing and its qualification

 Qualification of a freeze-dryer

 Design and qualification of CIP and WIP

Utilities

 Clean rooms

 Restricted-access barrier system (RABS) and containment technologies

 Purified water and water for injection

 Pure steam, compressed air

Process

 Basic requirements for aseptic manufacturing

 Sterile manufacturing

Qualification and validation

Organization of the qualification and validation process

Development of a validation master plan and qualification protocols

Design qualification

Warehouse qualification

Qualification of temperature-controlled storage areas

Qualification of online particle monitoring system

Qualification of sterile manufacturing equipment

Qualification of steam sterilizers and depyrogenation tunnels

Qualification of freeze-dryer

Sterile filtration validation

Cleaning validation

Media fill test

Computerized systems validation

Ethylene oxide sterilization. Validation of the sterilization process for a medical device

Aseptic Processing Practices and Process Validation

Non‑sterile process validation

Quality control