About
Close to 25 Years experience in the daily business of Sterile / Aseptic Production

Education

University of Innsbruck (Austria)
PhD in Microbiology

 

Employment

1988 - 1990 Validation Coordinator in Biochemie Kundl for a Sterile Plant /US Joint Venture Project

1991 – 1993: Dissertation , University of Innsbruck, Austria

1994 - 95 R&D  Strain Improvement Microbiology, Biochemie, Austria

1996 - 2012 , Head QA/ QC Microbiology in Sandoz GmbH, Kundl, Austria 

 

2013: Foundation of Gapp Quality GmbH

Ongoing:

Independent Consultant 

Experience

  • 25 years years experience in the daily business of Sterile/ Aseptic Production (for Bulk Pharmaceuticals/ Finish Dosage Forms and Biopharmaceuticals) and QA/ QC Microbiology (Sterility Testing/ LAL/ MET lab QC Methods)
  • Introduced two Rapid Microbiological Testing Methods at Sandoz (Chemscan/ ScanRDI 1996 and Millipore Rapid Micro Testing 2010)
  • Involved in 25 (successful) FDA audits as SME in the front line
  • Several F2F meetings at the FDA CDER or CBER, EMEA, EDQM
  • 1996 created a new Sterile Bulk Media Validation Approach
  • Set Up of new Media Fills/ EM programs
  • Training of clean room personnel

Experience

  • Introduction of Training Videos as effective training tool for clean room operators and lab technicians
  • Experience with Isolator Technology 
  • Head of Sandoz GmbH “Aseptic Task Force Group” 2000- 2012
  • Sandoz global “Troubleshooter” worldwide for sterility and compliance problems 
  • Created 2006 the Sterile Quality Risk Assessment (refer to the PDA publication 2011), rolled successfully out within all Novartis sites worldwide
  • Extensive Shop Floor activities/ experiences in the sterile production

    As consultant from 2013 on:

  • Man in Plant
  • Audits
  • Training Aseptic Operations  
  • Sterile Product Compliance Risk Assessments
  • Preparation and support of FDA Audits
  • QA Microbiology activities in start up of new aseptic filling lines (Cleanrooms/ Utilities/ Sterility Testing)
  • Workshops & Shop Floor Mentoring
  • Cell Culture Plants Start-Up
  • Upgrade Aseptic Processing production/ QA & QC systems
  • CAPA Verifications (FDA Follow Up Activities)
  • Batch Record Review and Certification