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QMS - Quality management system
- Supplier management
- Quality management health check
- Food safety assessments
- Transfer of quality systems
- Performance of self-inspection programs
- Supplier audits
- Setup of quality systems
- Preparation of GMP inspections such as e.g. FDA or EMEA
- Preparation of ISO 9000ff audits
- GxP systems
- General GMP rules
- Handling deviations – deviation excellence courses
- OOS/OOT – trainings
- Behavior training during audits
- analyse the actual (as-is) state of your quality management system and provide you with ideas on how to introduce improvements and how to implement them together.
- Assist you during shortages of staff in your quality management.
- perform internal as well as external audits for you.
- train your employees and condition them for audits and inspections (FDA / EMEA).
- develop your personal operational excellence strategy together.
- support your employees with failure analyses (Deviations and OOx).
- conduct efficiency enhancements using the Six Sigma method.
- generate concepts for packaging your clinal trial products and medicinal devices.