Quality audits in preparation for HPRA, FDA, EU, ISO 13485 and PS 9000 requirements and internal guidelines.
System specific GMP audits that focus on particular areas of concern. These can form the basis of a quality improvement plan.
Pre-regulatory inspections and reviews that provide invaluable experience to site personnel in handling inspections effectively and efficiently.
Audit team training of key site personnel.
Audit follow up, including preparation of improvement plans.
Implementation of CAPA (Corrective & Preventive Action) systems.
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