Options
Christian Mänder
Former Member
Title
Dr.
Last Name
Mänder
First name
Christian
Phone
+41 71 224 7266
Homepage
Now showing
1 - 10 of 13
-
PublicationType: journal articleJournal: PharmatechIssue: 14
-
PublicationType: journal articleJournal: Pharm Tech JapanVolume: 30Issue: 7
-
Publication21c Quality Management in the Pharmaceutical Industry(Editio Cantor Verlag, 2018)
;Basu, Prabir K. ;Calnan, Nuala ;Biehl, Sebastian ;Braun, Matthias ;Lamba, Sanjit S. ;Lehmann, Bernd ;Lima, Jose Mario ;Lupo, Marco ;Moloney, Conor ;Reddy, Madan M. ;Basu, Prabir K.Calnan, Nuala -
PublicationKonzepte - Modelle - Systeme(Carl Hanser, 2014)
;Seghezzi, Hans-Dieter ;Pfeifer, TiloSchmitt, RobertType: book sectionVolume: 6. überarbeitete Auflage 05/2014 -
PublicationMatching Problems with Tools(Springer Berlin Heidelberg, 2013)
;Basu, PrabirWerani, JürgenIn order to provide a profound understanding of the use of tools, it is necessary to discuss them in the context of objectives that can be reached by their application. A tool and its mere application are not just self-contained. This becomes apparent when looking at the further development of Deming's famous PDCA cycle by Kaoru Ishikawa. He expanded the two steps "Plan" and "Do" by an extra step each, making six steps out of the four: Determine goals and targets, determine methods of reaching goals, engage in education and training, implement work, check the effects of implementation and take appropriate action. These kinds of cycles are typical for many approaches in quality management/improvement. It is a pragmatic step-by-step approach for collecting data, analyzing them and deriving solutions (Fig. 18.1).Type: book section -
PublicationType: newspaper article
-
PublicationTowards the Operationalization of Production Systems: Simultaneously increasing effectiveness and efficiencyIn recent history, Multinational Corporations (MNCs) from all industries have established their own production systems based on Toyota’s unique success story. Nevertheless, industrial companies are still facing issues when it comes to the quantification of the influence of single system elements on the company’s overall performance. The following article presents an approach which allows decision makers to better determine site priorities, define more impactful improvement measures, and further leverage one’s own production system by using the steadily increasing data available in manufacturing.Type: newspaper articleJournal: Pharma Focus AsiaIssue: 24
-
PublicationHow to Embed ExcellenceHaving witnessed the evolution of operational excellence (OPEX), how do you implement it - and how do you ensure continued success? Here, we propose a new model.Type: newspaper articleJournal: The Medicine MakerIssue: 115
-
PublicationWhat are the 10 Hot Topics in Pharmaceutical Operational Excellence for 2015?: Status Quo Analysis from an Operations Management PerspectiveThe following article presents an overview on the 10 hot topics in regards to pharmaceutical manufacturing. This analysis is based on research work of St.Gallen Operational Excellence (OPEX) team from the University of St.Gallen. Perhaps not surprisingly one of the main issues is the increasing integration of OPEX and quality, which requires novel management approaches. This and further topics are described in order to be primed for upcoming changes.Type: newspaper articleJournal: Pharma Focus AsiaIssue: 22
-
PublicationPainting a Better Picture of QualityThe FDA's approach to quality oversight has evolved in recent years, particularly with the establishment of the new Office of Pharmaceutical Quality (OPQ). OPQ exists within the Center for Drug Evaluations and Research (CDER) as a single unit dedicated to product quality with a simple mission: "to assure that quality medicines are available for the American public". In 2013, the FDA announced in the publication of the FDA Administration Safety and Innovation Act (FDASIA) that they intended to examine the use of selected quality metrics (the exact metrics will be decided upon and collected during an FDA quality metrics program) to support their risk-based inspection program. And more recently, the FDA published its draft guidance for industry related to the quality metrics request (1).Type: newspaper articleJournal: The Medicine MakerVolume: 12Issue: 0915