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Name

Frank Wienen

Function

Senior Consultant,
Qualified Person

Dr Frank Wienen

   

Experience since 2003

  • PharmaKorell GmbH, DE-Lörrach
  • Novartis Pharma Produktions GmbH, DE-Wehr/Baden
  • Bayer Healthcare, DE-Grenzach-Wyhlen
  • Hoffmann-La Roche AG, DE-Grenzach-Wyhlen

Qualifications

  • Expert Pharmacist in Analytical Analysis, Bavarian Chamber of Pharmacists, DE-Munich
  • PhD in Pharmaceutical Sciences, University of Würzburg, DE-Würzburg
  • Pharmacist, State Examination, University of Bonn, DE-Bonn
  • Pharmazeutisch-Technischer Assistent, DE-Bonn

Experience so far

Qualified Person (German Pharmaceutical Legislation); Process Unit Head of Quality Management, Process Unit Head of Operations; Head of Production; Deputy Head of Production; responsible person for narcotic drugs (German Narcotic Drugs Act); Project Management -Site FDA Compliance project; Head of Quality Control; responsible for safety, GMP compliance, training status, training, improvement processes; manufacturing and packaging solid, semi-solid dosage forms; packaging of sterile dosage forms, clinical samples (IMP); Lead GMP Auditor; analytical method transfers, implementation of cleaning validation, sterilization processes; stability studies;