Autoren

Grad. in Civil Engineering Electric Engineering (Bingen Technical College and Kaiserslautern University)

since 1997 Boehringer Ingelheim Pharma GmbH & Co. KG with following special fields:

1997-1998 Computer Validation in pharmaceutical production (responsible for validation of automated production plants)

1998-2001 Head of various special projects in the field of data processing (e.g. introduction of a data collection system, securing supply to market during implementation of SAP R/3, millenium 2000 project) and expert responsibility for electrotechnical employees in pharmaceutical production

2001-2004 Head of Computer System Validation within Quality Operations Dept. (e.g. responsible for implementation of a harmonized quality assurance system for computer validation on a worldwide basis and implementation of 21 CFR Part 11 requirements)

2005 - 2009 Head of Training & Computer System Validation within Quality Operations Dept. (e.g. responsible for carrying out GxP-Training; also responsible for GxP compliant implementation and GxP compliant operation of superordinated computer systems)

2009 – 2010 Head of Group Systems & Governance within Supply Chain Management Dept. / BI Headquarter (e.g. responsible for Supply Chain Processes and the respective computerized systems used worldwide)

since 2010 Head of Group Computerized Systems, Validation & Compliance within Q & EHS / BI Headquarter (e.g. responsible for setting worldwide standards for Computer System Validation)

Publications at Maas & Peither GMP Publishing:

• GMP-MANUAL
  (Co-Author of Chapter 10.D Methodologies to be Used to Facilitate Risk Management and chapter 10.I Failure Mode Effects Analysis (FMEA))