Koch Consulting provides experience in Project Management and Continuous improvement, Process optimization and CTPAT (USA)/ AEO (Europe).
• GMP/ GDP/ GCP/GLP regulations, GMP+, ISO 9001
• Project Management. Leadership
• Quality Management System (QMS) and IT QMS
• IT Compliance and Security
• Data integrity program
• Validation and Periodic review
• Continuous improvement program
• Process optimization
• Distribution and Supply chain Management
• Change Control and Change Management
• Deviations, CAPA
• Complaints
• External and Internal Audit
• Collaboration with CMO and CRO
• CTPAT (USA) or AEO (Europe)
• Performing in-house and online GMP and GDP training and coaching of the technical and academic staff.