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:
✔ 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
✔ General requirements to process equipment
✔ Equipment for sterile manufacturing and its qualification
✔ Qualification of a freeze-dryer
✔ Design and qualification of CIP and WIP
✔ Restricted-access barrier system (RABS) and containment technologies
✔ Purified water and water for injection
✔ Pure steam, compressed air
✔ Basic requirements for aseptic manufacturing
✔ Sterile manufacturing
✔ 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
✔ Good practices for pharmaceutical quality control laboratories
✔ Process-analytical technology