Autoren

1988-1994 Doctorate in Pharmaceutical Technology
(University of Saarland, Germany, Prof. Dr. Loth)

1994-1997 Gödecke AG (Germany), Quality Assurance: cleaning validation (development and implementation of an FDA compliant validation concept for a newly built manufacturing plant for solid forms, FDA Audit 1996), qualification (production equipment, laboratory equipment, media), change control, audit, cooperation with consultants

1997-2000 Gödecke AG (Freiburg, Germany) Process Technology:
Product transfers, Scale up and validation of manufacturing processes, Process optimization, Scale up and validation of NDA products; FDA pre-approval inspection 1999

2000-2005 Pfizer GmbH Arzneimittelwerk Gödecke (Freiburg, Germany), Quality Management: Project work during maternity leave, e.g. update of master plans, translation of policies, preparation of annual product reviews

2005-2008 Pfizer GmbH Arzneimittelwerk Gödecke (Freiburg, Germany), Technical Services: Process optimization, Raw material qualification; international Co-Development, Risk Management, Scale up and validation of NDA products, Quality by Design, Right First Time, Six Sigma Projects; FDA pre-approval inspection 2007

since 2008 Maas & Peither AG GMP Publishing, editorial department

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Author of  chapters 8.B Validatability of cleaning procedures to 8.J Cleaning validation documentation (example))