Qualified person according to §15 german medicinal product act; Clinical studies (OL/DB); Investigational medicinal products; Solid dosage forms (tablets, capsules); Sterile dosage forms; Batch record review; Master batch record; Verification and approval of specifications; Deviations; Customer complaints; CAPAs; Preparation and review of work instructions, forms and checklists; Project leader for genetic engineering operations and installations (S1/S2); Biosafety Officer (S1/S2); Risk assessments for GMOs; Inspections by competent authorities (S1/S2); Self inspections; Audits; Trainings