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GMP-Verlag
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Autoren

 

 

Pharmacist (University Erlangen, Germany),  Dr. rer. nat. in Pharmaceutical Technology  (University Marburg, Germany)

1987-1989 3M Medica/ Kettelhack-Riker, Borken (Germany)
Project Management in galenical development; development of an oral Drug Delivery System made of pellets containing starch with an enzyme-controlled active ingredient release; preparation of clinical trial samples

1989-1994 Sandoz Pharma AG, Basel (Switzerland)
Pharmaceutical Development, Drug Delivery Systems Dept., head of laboratory for the development of nasal and pulmonary dosage forms with systemic effect

1994-1997
Sandoz Pharma AG, Basel
Technical R & D - Quality Assurance Unit as assistent to the head of department, establishment of  a quality unit which reflects the special needs of R&D, compilation of a quality manual for pharmaceutical development

1997-2010 Novartis Pharma AG
Quality Assurance Unit Technical R&D and Biotech Development and Production, Part-time in Quality Systems and GMP Training, freelance work in GMP Training, emphasis on process validation

2002-2004 Study of "Teaching, Learning, Leading" at PH Freiburg

since 2011 GMP Instructor

Publications at Maas & Peither GMP Publishing:

  • GMP-MANUAL
    (Co-author of Chapters 6.E.1 Examples of IQ plans and 6.F.1 Examples of OQ plans)

    (Author of Chapters 7 Process Validation (chapter 7.B Validation - a key element of quality assurance to chapter 7.H Validation protocol and report), 16 Research and Development and 18.H Questionnaire for preparing GMP-inspections)