* Analysis of existing CAPAs medical technology.
* Processing CAPAs for FDA Audit.
* Change Management
* support the client during the preparation of the FDA
Audits and external audits as well as internal audits, review and
Development of practicable Löxsungen.
* Complaint management, claim handling, internal and external takeover
Complaints, processing of NCRs (non-conformity requests).
* Acquisition of NCRs in the CAPA process
* Perform legacy reviews from CAPAs to status quo
* Creation and modification of SOPs
* Review of CAPAs and preparation of remediation reports according to
Requirements of the FDA
* Leading the CAPA Review Board, supporting the external CAPA
Consultants in the development of different levels, monitoring
and monitoring the CAPA activities.
* Batch tracking in field action activities, monitoring and
Releases of the lock camp.
* Documentation of the return of batches from the
Quarantine storage.
Creation and maintenance of the necessary monitoring reports
* Assistance with strategic review, monitoring of
continuous improvement with project management methods,
effective communication with US and European companies in
Questions of quality.
* Introduction of practical design investigations, development and
Introduction of standard procedures, processes and systems for CAPA
Risk analysis and process FMEA.