Training
Basics of GMP
GMP principles (Quality system and comparison of GMP and ISO approach, Quality assurance, Quality control, Quality risk management, Documentation)
Documentation (Document types, Document creation and management, Good documentation practice, Document storage, Specifications, Production regulations, Records)
Production (Production requirements, Prevention of cross-contamination in production, Technical and organizational measures, Validation, Starting materials)
Quality control (Good practice in control laboratory, Documentation, Sampling, Testing)
Qualification and validation (Organization and planning of qualification and validation, Documentation, Qualification phases for equipment, premises, media and systems, Retraining, Process validation, Change management)
Quality risk management (Process quality risk management, Process quality risk management, Integration of QRM into the activities of industry and regulators)
Price
3 705 EUR without VAT
Course time
12 hours
Contact
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