
Name
Stefanie Schmidt
Function
Senior Consultant
Dr Stefanie Schmidt
Experience since 2010
Qualifications
Experience so far
Qualified Person (German Drug Law); Quality Assurance; Head of Production; Contract Manufacturing; Manufacture and Testing of Sterile Liquid and Lyophilized Medicinal Products (Aseptic Filling, Terminal Sterilization, Visual Inspection, Packaging); Manufacture of Solid and Liquid Medicinal Products; Batch-Record-Review; CAPA-, Deviation- and Complaint Management; Change-Control; Product Quality Review; Quality Agreements; Preparation of Master Manufacturing and Packaging Instructions; Transfer of Products and Equipment; Process Validation; Training; Continuous Improvement Process; Audits and Inspections



