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Investigating Human Error in Pharmaceutical Manufacturing

Lecture which took place at ILMAC Lausanne, Forum
23 October 2017

On average, almost 30% of quality defects were attributed to human error and investigations into these root causes are generally poor and superficial. There were often no sustainable CAPAs (corrective and preventive actions) defined, and the corrective action was mainly just re-training. So what is the best way to deal with deviations and incidences which seem to be caused by human error?

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List of Publications

on peer-reviewed journals
6 September 2013

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Process Development and Multikilogram Syntheses of XL228

Org. Process Res. Dev., 2013, 17 (8), pp 10661073
6 September 2013


Safety Assessment for the Scale-up of an Oxime Reduction with Melted Sodium in Standard Pilot-Plant Equipment

Org. Process Res. Dev., Article ASAP, 2012, DOI: 10.1021/op300101d
2 June 2012


Identification of a 1,2,4,5-Tetraoxane Antimalarial Drug-Development Candidate (RKA 182)

Angewandte Chemie International Edition, 49: 56935697. doi: 10.1002/anie.201001026
13 July 2010


Implementation of a High-Temperature Claisen Approach for Early Phase Delivery of a Benzopyran Derivative

Organic Process Research & Development 2010, 14, 8591
18 April 2010


Preparation of a HMG-CoA Reductase Inhibitor via an Optimized Imidazole-Forming Condensation Reaction

Organic Process Research & Development 2008, 12, 11831187
18 April 2008


Development of a Scalable Synthetic Route to GSK369796 (N-tert-Butyl Isoquine), a Novel 4-Aminoquinoline Antimalarial Drug

Organic Process Research & Development 2008, 12, 294297
18 April 2008


2-(Diethylamino)ethanethiol, a New Reagent for the Odorless Deprotection of Aromatic Methyl Ethers

J. Org. Chem., 2006, 71 (18), pp 71037105
18 April 2006


Chiroptical Properties of Some Monoazapentahelicenes

J. Phys. Chem. A, 2004, 108 (52), pp 1175211761
18 April 2004


First Safe and Practical Synthesis of 2-Amino-8-hydroxyquinoline

Organic Process Research & Development 2004, 8, 663-665
18 April 2004


Development of a Scaleable Route for the Production of cis-N-Benzyl-3-methylamino-4-methylpiperidine

Org. Process Res. Dev., 2003, 7 (1), pp 115120
18 April 2003


Large-Scale Preparation of 3-Methyl-4H-[1,2,4]oxadiazol-5-one, Potassium or Sodium Salt

Organic Process Research & Development 2002, 6, 896-897
18 April 2002


16 February 2018
CARBOGEN AMCIS Announces a Successful Swissmedic Inspection of its Site in Vionnaz, Switzerland

11 October 2017
CARBOGEN AMCIS Announces a Successful FDA Inspection of its Headquarters Site in Bubendorf, Switzerland

21 July 2017
CARBOGEN AMCIS Sites at Bubendorf, Aarau and Neuland in Switzerland Successfully Pass Swissmedic Inspection

DCAT week

World ADC Berlin