Plant and equipment qualification

Creation and moderation of risk analyses, development of tailor made GMP qualification strategies, creation of master plans, DQ, IQ, OQ, Performance Qualification (Process & automated recipes, media fill, smoke studies, aseptic work), planning, coordination and handling of all qualification / validation activities, automation system, computer system validation (CSV).

Inspection management (customers, national authorities, FDA)

Inspection management & logistics, coordination of preparation, identification of hot topics and preparation focuses, quality metrics, document review, pre-inspections, subject matter expert training

GMP compliant organisation and quality assurance

Quality by Design in accordance with ICH Q8, risk management according to ICH Q9, GMP life cycle management according to ICH Q10, creation of pharmaceutical QM systems, creation of SOPs, training of project and operating employees