Challenges and opportunities in enterprise-wide optimization in the pharmaceutical industry

JM Laínez, E Schaefer, GV Reklaitis - Computers & chemical engineering, 2012 - Elsevier
Enterprise-wide decision support applications have received increased attention in the
chemical process industry in the last decade. In this paper applications, which have real or …

[HTML][HTML] Knowledge-Based Assessment Applied to Lean Brazilian Toyota Plants: Employees' Perceptions

J Muniz Jr, VB Ribeiro, N Pradhan - International Journal of …, 2021 - igi-global.com
This paper proposes knowledge-based assessment applied to Brazilian Toyota plants which
practice Lean manufacturing to evaluate work, production, and knowledge factors based on …

[BOOK][B] Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

GV Reklaitis, C Seymour, S García-Munoz - 2017 - books.google.com
Covers a widespread view of Quality by Design (QbD) encompassing the many stages
involved in the development of a new drug product. The book provides a broad view of …

A workflow modeling system for capturing data provenance

GS Joglekar, A Giridhar, G Reklaitis - Computers & chemical engineering, 2014 - Elsevier
A workflow is an abstraction of the steps associated with the underlying work process and is
typically modeled as a directed graph. The workflow concept under its various …

A Blueprint for Knowledge Management in the Biopharmaceutical Sector

P Kane - 2018 - arrow.tudublin.ie
This research examined current industry Knowledge Management (KM) methodologies and
capabilities in order to gain insights into the level of maturity and understanding of KM within …

Knowledge Management in Support of QbD

G Joglekar, GV Reklaitis, A Giridhar… - … Quality by Design for …, 2017 - Wiley Online Library
This chapter discusses the role of knowledge management systems in providing a structured
framework for recording, using, and learning from the data that is generated over the life …

Perspective on systems engineering advances in process and product design

GV Reklaitis - Proceedings of the 8th International Conference …, 2014 - books.google.com
Process systems engineering, which in content if not in title has a history almost as old as
the chemical engineering discipline itself, can rightly be proud of having had a remarkable …

Evaluation of sampling spacing in pharmacokinetic studies using six sigma method

T Grabowski, A Raczyńska-Pawelec… - … of pharmacokinetics and …, 2014 - Springer
Key elements of pharmacokinetics (PK) studies include both, the number of sampling points
(NSP) as well as the spacing between the sampling points (SSP). Optimization of the SSP is …

14.6 Design Space

S Blender - … Quality by Design for Pharmaceutical Product …, 2017 - Wiley Online Library
The concept of design space is a key component of QbD implementation for pharmaceutical
products. ICH Q8 (R2) defines design space as “the multidimensional combination and …

Process Systems Engineering: Quo Vadis?

GVR Reklaitis - Computer Aided Chemical Engineering, 2012 - Elsevier
Process systems engineering, which in content if not in title has a history almost as old as
the chemical engineering discipline itself, can rightly be proud of having had a remarkable …