Consultancy

 

The consulting services by Dr. Klaus Haberer have been very helpful for numberous customers during the past years. Due to his well founded academical knowledge and his great practical experience, Dr. Haberer has been a valuable help for solving many problems in various projects and many of those with a high complexity. Dr. Haberer is one of the most recognized experts worldwide on his field, and he offers his expertise to support you within your microbiological matters.

 

This page gives you an overview on the competence and experience of Dr. Haberer.

 

 

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Academic and professional career

 Academic career 

1966 – 1973Studies of Biology and Biochemistry at the Universities of Tübingen and Köln, Germany
1973Ph.D. in physiological chemistry from University of Köln, Germany
Biochemistry (Lipids) of Cell Membranes
1974 - 1981

Postdoctoral studies in microbiology at the University of Rochester, USA, and
at the University of Ulm, Germany

Biology of Mycoplasmas and Mycoplasma Viruses

Methods:

 

  • Biochemisty of nucleic acids
  • Electron Microskopy
  • Characterization of host cells, viruses and proteins
  • Biology and biochemistry of virus replication
1983

Privatdozent (Associate Professor) in Microbiology (University of Ulm)

 

15 years of annual courses to undergraduate students in microbiological analytics and quality assurance

 

 

 Professional career 

 

 

1981 - 1982Project Management at IPHAR-Institut für Klinische Pharmakologie, Höhenkirchen, Germany
1983 - 1986Head of Microbiological Quality Control at Hofmann-La Roche-AG, Grenzach, Germany.
1986 - 1999Head of Microbiological Quality Control and later Director of Microbiology Global Quality Operations at Hoechst Marion Roussel AG in Frankfurt, Germany.
since 1999Managing Director of Compliance Advice and Services in Microbiology GmbH at Cologne, Germany, his own consultant company with microbiological laboratory service.

 

 

 

Professional Experience

 

 Clinical Pharmacology

 

Project management in immunopharmacological phase1 and phase 2 clinical studies;

Planning and equipping of a microbiological laboratory for clinical and preclinical studies under GLP and GCP guidelines.

 

 

 Microbiological Quality Control and Quality Assurance 

 

  • Environmental monitoring and control of plants for production of sterile pharmaceuticals under GMP conditions

 

  • Pharmacopoeial methods for microbiological quality control under GMP conditions

 

  • Validation of sterilization procedures and aseptic procedures

 

  • Planning and development of microbiological QA/QC procedures for pharmaceutical developmental products

 

  • Setting of microbiological standards and guidelines in a globally operating pharmaceutical company

 

  • Head of a microbiological QC laboratory for 3 years

 

  • More than 10 years experience as head of quality control / quality assurance department in the pharmaceutical industry

 

  • Officially recognized Qualified Person under German drug law

 

  • International auditing practice for many years

 

  • Training in microbiological techniques, methods, practices and their validation worldwide

 

 

 Professional Trainings

 

  • Numerous public presentations in collaboration with professional training organizations (Publication list upon request)

 

  • Regular appearance as speaker, panelist or chairman in international congresses 

 

 

 

Representation in professional committees

 

 Representation in professional committees

 

since 1986

Associated German expert for European Pharmacopoeia: Expert Group 1
Microbiology:

Expert in various ad hoc working parties and European delegate for international harmonization of microbiological methods
1987 - 1992Member of the microbiological working party of APV (Arbeitsgemeinschaft Pharmazeutischer Verfahrenstechnik)
1987 - 1992DIN/ ISO: Member of the standardization committees for steam sterilization and membrane filtration in DIN/NAMed
since 1990Member of the BSE-steering committee of the German Pharmaceutical Manufacturers Associations
since 1994Member of the German Mirror Committee for CEN Methods of Sterilization

since 1994

 

 since 1998

Member of the working group ISO TC 198/WG 9 Aseptic Processing

 

Chairman of the group
since 1995PDA Member of various task forces
1996Founding member of the European PDA Chapter
1997-1999Chairman of the task force Parametric release
 Member of PDA working group: Validation of Steam Sterilisation
 Member of the PQRI working group (by invitation) for discussion of specific questions of FDA in course of revision of the FDA-Draft (2002) for Aseptic Processing of Pharmaceuticals
since 2005PDA Member of „Scientific Advisory Board“