QUALITY MANAGEMENT & AUDITING

Quality Management

• Interim quality management
• Implementation of quality systems
• Preparation and accompaniment of client and authority inspections (e.g.: FDA, local authorities)
• System analysis and troubleshooting
• Training system management
• Handling of deviations, changes, corrections, and preventive measures
• Drafting of standard operating procedures
• Creation and implementation of concepts for supplier qualification and re-qualification

Auditing

• Supplier audits in accordance with applicable guidelines (GMP, GLP, GDP, GCP, ISO standards) and requirements of the client
• Internal audits in order to prepare for inspections by authorities
• Routine internal audits
• Audits of plasma donation centers
• Audits in the light of recent events
• Audits on documents and records
• Due diligence audits