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Qualitätsmanagement - Systeme

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
Audits und Inspektionen im Qualitätsmanagement

Audits

  • Preparation of GMP inspections such as e.g. FDA or EMEA
  • Preparation of ISO 9000ff audits
Trainings im Qualitätsmanagement

Training

  • GxP systems
  • General GMP rules
  • Handling deviations – deviation excellence courses
  • OOS/OOT – trainings
  • Behavior training during audits

We

  • 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.

Dietmar Weitzel u. Dirk Wenzel
Partnerschaftsgesellschaft mbB

Head Office
Hopfengarten 28A
D-35043 Marburg
Tel.: +49 6421 9929 28

Lohra Office
Zur Burg 3
D-35102 Lohra - Willershausen
Tel.: +49 6462 9168312