My services

my services offered include:

Evaluation of existing production processes and deriving conclusions regarding compliance with standards, as well as opportunities for process optimization and enhancing process security and stability
Accompanying procurement processes, including the creation and alignment of specifications and requirements documents, supplier evaluation and selection, project monitoring at the supplier’s site, Factory Acceptance Testing (FAT), transportation, installation, commissioning and Site Acceptance Testing (SAT)
Qualification of equipment and facilities / Validation of processes including peripherals
Temporary Quality project management (data analysis, change management, CAPA)
Assessment of changes in the regulatory environment for existing Quality Systems and production processes
Technology research, evaluation, development and implementation
Design transfer from development status to serial production
Product and process risk analyses including peripherals (particularly FMEA)
Facilitation of workshops on Quality Management and risk assessment / elimination
Research, evaluation, and implementation of second sources (alternative suppliers)
Regulatory and technical supplier qualification
Patent research and support for patent applications
Audit preparation and follow-up, conducting preventive mock audits, in-house or at suppliers/customers site

advanced knowledges:

Fabrication and processing of hollow fiber membranes and modules, particularly for dialysis and blood-oxygenation, but also for water purification and biotechnical applications (hollow fiber based bioreactors and harvesting filters)
Systems for the production, storage and distribution of purified water and WFI
Packaging processes (primary and secondary packaging), particularly for sterile packaging
according to DIN ISO 11607-1 and -2
Workplace and process design in cardboard engineering

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