Autoren

Since 1992 he has been with Roche leading a preparative and analytical laboratory, in project management, as production manager, in Quality Assurance and in Quality Management.

In april 2003 he joined the Global Quality Department in Pharma Global Technical Operations. Beside auditing and issue management in his function as deputy head of the external relations department his main focus is on Good Manufacturing and Distribution Practice (GMDP) - Intelligence, supporting the Pharmaceutical Quality System (PQS), Quality Risk Management and global Process Mapping of Roche.
He represents on behalf of Roche in the Manufacturing & GMP AdHoc group of EFPIA and is delegated as member of the EFPIA topic teams e.g. on "Process Analytical Technology (PAT) and Design space" and "Foreign Regulatory Health Inspections". He is member and the European representative in the Parenteral Drug Association (PDA) Regulatory Affairs and Quality Committee (RAQC).
He was a member of the ICH Expert Working Group (EWG) on Quality Risk Management (ICH Q9) as delegate of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and chaired of the writing team for the ICH Q9 briefing pack. He acts as EFPIA representative in the ICH Quality Implementation Working Group (IWG) of the guidelines on Pharmaceutical development (ICH Q8), Quality Risk Management (ICH Q9) and Pharmaceutical Quality Systems (ICH Q10).

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Co-author of Chapter 10 Considerations on Risk Management)