We have a close network of authority, industry and university representatives. From this pool of experts, we provide you a qualified mentor. We advise on the implementation of subject specific and interdisciplinary challenges in the ares of:

Quality Assurance

• Establishment of quality management systems
• Document management (SOP, specifications, master plans)
• GMP training
• Qualification of suppliers (packaging, active ingredients, technical service providers, installation construction)
• Risk management
• Cleaning validation
• CAPA
• Deviation management
• Hygiene monitoring
• Transport management and validation
• Technical qualification of transport systems (active and passiv) transport simulation test
• Preparation, monitoring and post-processing of audits

Production

• Process validation
• Batch record review
• Product quality report
• Warehousing in according to GMP

Premises and Facilities

• Supervision of renovations and new construction
• Qualification functions (premises, facilities, equipment)
• Technical building services
• Maintenance and repair of premises, media and equipment

Quality Control

• Sample measurement
• Testing and evaluation of raw material and products
• Equipment qualification and calibration
• Validation of methods
• Method transfer
• Stability inspection
• Preparation for GLP certification

Information Technology

• Validation of computer-aided systemy (GAMP)

Packaging

• GMP basic training in the area of packaging: packaging and processes
• Assessment and manufacture packaging

Management Techniques

• Project management
• Process analysis and optimisation
• Trouble Shooting
• Successful presentation
• Effective structuring of meetings
• Intercultural training

Further topics are available on request!

Dr. Martin Bornhöft
Telephone: ++49-6161 – 97 69 30
e-mail: mb@apv-mainz.de

Dr. Katrin Kälkert
Telephone: ++49-6131 – 97 69 40

e-mail: kk@apv-mainz.de