GMP Trainings
- Good manufacturing practices (GMP)
- Good documentations practices (GDP)
- Good laboratory practices (GLP)
- Quality management system (QMS)
- change Control
- Deviation
- CAPA
- Risk based thinking & analysis
- Pharmaceutical quality system as per ICH Q8, ICH Q9 & ICH Q10 guidelines
- facility designing & qualification
- HVAC system designing & qualification
- water system designing & 3 phase qualification
- Compressed air qualification
- Nitrogen system qualification
- Train the trainers
- Technology transfer
- Analytical method transfer
- Auditing skills
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How to face customer & regulatory audits
- ICH, WHO, US FDA, EU GMP, ISO & NSF guidelines
- Equipment qualification
- Process validation
- Cleaning validation
- Analytical method validation
- Aseptic processing of APIs & drug products
- Media fill validation
- Any other specific topic as per training need identification of employee.
Employees working into following industries are trained on above topics:
- Pharmaceutical Formulations/Drug Products Manufacturing Facility Tablets, Capsules, Liquid Orals, Injections & Ointment)
- Food Products manufacturing facility
- Medical Devices Manufacturing facility
- API manufacturing facility (Sterile & Non-Sterile)
- Key Starting Material and Intermediate Manufacturing facility
- Contract research organizations/laboratories
- University and educational institutions
- Good manufacturing practices (GMP)
At the end of training programme, all attendees are evaluated based on specific questionnaires and certificate of attendance and successful completion is given to all attendees by SK Pharma Consultants.
