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AVITSENA

Understand GMP inspections from both sides of the table. This course explains inspection principles, types and approaches, how inspectors think and how an inspection unfolds. You will design and run an effective self-inspection programme, report and score findings, and audit contract manufacturers, suppliers and API manufacturers. Dedicated modules cover the FDA approach and focus areas, preparing content and addressing known weaknesses, organisational preparation, behaviour and communication in the inspection room, handling observations and responses, and sustaining inspection readiness. A final assessment and a certificate of completion are included.