The Management Of Chemical Process Development In The Pharmaceutical Industry

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The Management of Chemical Process Development in the Pharmaceutical Industry

Author : Derek Walker
Publisher : John Wiley & Sons
ISBN 13 : 0470259507
Total Pages : 424 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis The Management of Chemical Process Development in the Pharmaceutical Industry by : Derek Walker

Download or read book The Management of Chemical Process Development in the Pharmaceutical Industry written by Derek Walker and published by John Wiley & Sons. This book was released on 2008-03-03 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work. This book illustrates practical considerations through many examples of the successful direction and integration of the activities of chemists, analysts, chemical engineers, and biologists, as well as safety, regulatory, and environmental professionals in productive teams. Moreover, this reference provides guidance on: Directing and carrying out specific tasks and courses of action Making and communicating clear and achievable decisions Solving problems on the spot Managing the administrative aspects of chemical process development The author, Dr. Derek Walker, has directed chemical process development work for four decades, combining firsthand chemical synthesis experience with many other disciplines needed to create chemical processes. You will benefit from his advice and unique insights into: Understanding the workings of matrix organizations Defining missions and creating action plans Developing interdisciplinary approaches to problem solving Holding review meetings, revising goals, and motivating staff Prioritizing programs and responses to emergencies In addition, you'll learn how successful chemists, in collaboration with other disciplines, define the best (green) chemistry for process scale-up, including accommodating FDA requirements in the last process steps and addressing safety and environmental matters early in their work. Case studies provide incisive perspective on these issues. A chapter on recognizing and patenting intellectual property emphasizes the importance of comprehensive literature surveys and understanding invention. A chapter on the future challenges you to think beyond narrow constraints and explore new horizons.

Pharmaceutical Process Development

Author : John Blacker
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733074
Total Pages : 374 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Process Development by : John Blacker

Download or read book Pharmaceutical Process Development written by John Blacker and published by Royal Society of Chemistry. This book was released on 2011-08-17 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry

Author : Someswara Rao
Publisher : John Wiley & Sons
ISBN 13 : 047031995X
Total Pages : 1 pages
Book Rating : 4.4/5 (73 download)

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Book Synopsis The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry by : Someswara Rao

Download or read book The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry written by Someswara Rao and published by John Wiley & Sons. This book was released on 2007-04-02 with total page 1 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book brings together the chemical strategies used in the optimisation of organic reactions and processes, and highlights the practical and technological options available. This book offers: an encyclopedic treatment of organic chemistry from an industrial, process research and development, and manufacturing point of view plenty of examples to illustrate the scope and limitation of the strategies a comprehensive index organised by topic, reaction type, and reagent an extensive literature survey. This is an essential and comprehensive guide for experienced practitioners of chemical process research and development, fresh recruits to chemical industry R&D divisions, and academics who are interested in interacting with the chemical industry, optimising their synthetic strategies, and enriching the field of atom economy.

Chemical Engineering in the Pharmaceutical Industry

Author : David J. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1118088107
Total Pages : 1431 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2011-03-10 with total page 1431 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book deals with various unique elements in the drug development process within chemical engineering science and pharmaceutical R&D. The book is intended to be used as a professional reference and potentially as a text book reference in pharmaceutical engineering and pharmaceutical sciences. Many of the experimental methods related to pharmaceutical process development are learned on the job. This book is intended to provide many of those important concepts that R&D Engineers and manufacturing Engineers should know and be familiar if they are going to be successful in the Pharmaceutical Industry. These include basic analytics for quantitation of reaction components– often skipped in ChE Reaction Engineering and kinetics books. In addition Chemical Engineering in the Pharmaceutical Industry introduces contemporary methods of data analysis for kinetic modeling and extends these concepts into Quality by Design strategies for regulatory filings. For the current professionals, in-silico process modeling tools that streamline experimental screening approaches is also new and presented here. Continuous flow processing, although mainstream for ChE, is unique in this context given the range of scales and the complex economics associated with transforming existing batch-plant capacity. The book will be split into four distinct yet related parts. These parts will address the fundamentals of analytical techniques for engineers, thermodynamic modeling, and finally provides an appendix with common engineering tools and examples of their applications.

Research and Development Management in the Chemical and Pharmaceutical Industry

Author : Peter Bamfield
Publisher : John Wiley & Sons
ISBN 13 : 3527606343
Total Pages : 280 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Research and Development Management in the Chemical and Pharmaceutical Industry by : Peter Bamfield

Download or read book Research and Development Management in the Chemical and Pharmaceutical Industry written by Peter Bamfield and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Mastering management skills is hard to achieve by newcomers starting their careers in the chemical industry. The message coming from there is that good chemists swiftly have to become good managers if they are to survive and progress in today's competitive climate. This book is designed to help guide younger R & D chemists to ways in which they can quickly evolve skills which are built around three factors - people, knowledge and time. It covers the management of scientific personnel, management within a variety of R & D organisational structures, creating a climate of innovation, the management of projects including the time management and communication aspects of the job. The author, Peter Bamfield, is now working as a consultant. Due to his long experience in the chemical industry, he was elected President of the Royal Society of Chemistry's Industrial Affairs Division. This second edition of the book has been revised and updated to take recent global developments and restructuring in the chemical industry into account, as well as the rising importance of information technology in management.

The Chemistry Of Process Developmet In Fine Chemical & Pharmaceutical Industry 2/Ed

Author : C. Somerswara Rao
Publisher :
ISBN 13 : 9788186299777
Total Pages : 1311 pages
Book Rating : 4.2/5 (997 download)

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Book Synopsis The Chemistry Of Process Developmet In Fine Chemical & Pharmaceutical Industry 2/Ed by : C. Somerswara Rao

Download or read book The Chemistry Of Process Developmet In Fine Chemical & Pharmaceutical Industry 2/Ed written by C. Somerswara Rao and published by . This book was released on 2006 with total page 1311 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book Offers:* An Encyclopedic Treatment Of Organic Chemistry From An Industrial, Process Research And Development, And Manufacturing Point Of View * Plenty Of Examples To Illustrate The Scope And Limitation Of The Strategies* A Comprehensive Index Organised By Topic, Reaction Type, And Reagent And An Extensive Literature Survey.

Pharmaceutical Process Development

Author : A. John Blacker
Publisher : Royal Society of Chemistry
ISBN 13 : 1849731462
Total Pages : 375 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Process Development by : A. John Blacker

Download or read book Pharmaceutical Process Development written by A. John Blacker and published by Royal Society of Chemistry. This book was released on 2011 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Pharmaceutical Process Development' is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry and informs them about the breadth of the work carried out in chemical research and development departments.

Process Chemistry in the Pharmaceutical Industry, Volume 2

Author : Kumar Gadamasetti
Publisher : CRC Press
ISBN 13 : 9781420008357
Total Pages : 520 pages
Book Rating : 4.0/5 (83 download)

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Book Synopsis Process Chemistry in the Pharmaceutical Industry, Volume 2 by : Kumar Gadamasetti

Download or read book Process Chemistry in the Pharmaceutical Industry, Volume 2 written by Kumar Gadamasetti and published by CRC Press. This book was released on 2007-12-10 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates. The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends. Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.

The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry

Author : C. Someswara Rao
Publisher :
ISBN 13 : 9788186299500
Total Pages : 1277 pages
Book Rating : 4.2/5 (995 download)

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Book Synopsis The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry by : C. Someswara Rao

Download or read book The Chemistry of Process Development in Fine Chemical and Pharmaceutical Industry written by C. Someswara Rao and published by . This book was released on 2004 with total page 1277 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Chemical Engineering in the Pharmaceutical Industry

Author : Mary T. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 111928550X
Total Pages : 1435 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Handbook for Chemical Process Research and Development

Author : Wenyi Zhao
Publisher : CRC Press
ISBN 13 : 1315350203
Total Pages : 1170 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Handbook for Chemical Process Research and Development by : Wenyi Zhao

Download or read book Handbook for Chemical Process Research and Development written by Wenyi Zhao and published by CRC Press. This book was released on 2016-11-03 with total page 1170 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Handbook for Chemical Process Research and Development focuses on developing processes for chemical and pharmaceutical industries. Forty years ago there were few process research and development activities in the pharmaceutical industry, partially due to the simplicity of the drug molecules. However, with the increasing structural complexity, especially the introduction of chiral centers into the drug molecules and strict regulations set by the EMA and FDA, process R&D has become one of the critical departments for pharmaceutical companies. This book assists with the key responsibility of process chemists to develop chemical processes for manufacturing pharmaceutical intermediates and final drug substances for clinical studies and commercial production.

Chemical Engineering in the Pharmaceutical Industry

Author : David J. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1119285860
Total Pages : 1172 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-04-23 with total page 1172 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying Presents updated and expanded example calculations Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

Handbook for Chemical Process Research and Development

Author : Wenyi Zhao (Chemist)
Publisher :
ISBN 13 : 9781032264615
Total Pages : 0 pages
Book Rating : 4.2/5 (646 download)

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Book Synopsis Handbook for Chemical Process Research and Development by : Wenyi Zhao (Chemist)

Download or read book Handbook for Chemical Process Research and Development written by Wenyi Zhao (Chemist) and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This fully updated second edition reflects the significant changes in process chemistry since the first edition and includes more common process issues such as safety, cost, robustness, and environmental impact. Some areas have made notable progress such as process safety, stereochemistry, new reagents and reagent surrogates. Forty years ago there were few process research and development activities in the pharmaceutical industry, partly due to the simplicity of drug molecules. With increasing structural complexity especially the introduction of chiral centers into drug molecules and stricter regulations, process R&D has become one of the critical departments for pharmaceutical companies"--

Principles of Process Research and Chemical Development in the Pharmaceutical Industry

Author : Oljan Repic
Publisher : Wiley-Interscience
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Principles of Process Research and Chemical Development in the Pharmaceutical Industry by : Oljan Repic

Download or read book Principles of Process Research and Chemical Development in the Pharmaceutical Industry written by Oljan Repic and published by Wiley-Interscience. This book was released on 1998 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This text discusses the functions of Process R&D (research and development), which involves the method of transforming a research synthetic procedure into a plant process and the key aspects of a synthesis that must be considered when scaling up a process. Topics consist of: basic principles of chemical development; techniques for the minimization of by-product impurities; criteria for cost-effective synthesis of enantiopure compounds by resolutions; asymmetric synthesis, and "chiral pool" strategy; synthesis for labeling substances with hydrogen or carbon isotopes; and last, licensing.

Research and Development in the Chemical and Pharmaceutical Industry

Author : Peter Bamfield
Publisher : John Wiley & Sons
ISBN 13 : 3527608656
Total Pages : 289 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Research and Development in the Chemical and Pharmaceutical Industry by : Peter Bamfield

Download or read book Research and Development in the Chemical and Pharmaceutical Industry written by Peter Bamfield and published by John Wiley & Sons. This book was released on 2006-12-13 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide for younger R&D chemists as to how they can quickly evolve skills built around three factors -- people, knowledge and time. It covers the management of scientific personnel, management within a variety of R & D organizational structures, creating a climate of innovation, the management of projects including the time management and communication aspects of the job. As such, it teaches the vital managerial aspects of scientific jobs in industry, which are not taught at university, providing a deep and detailed insight into the intricacies of managing research. The text is divided neatly into four sections: * Harnessing the Human Resource * Organising for an Innovative Environment * Creativity and Innovation * Project Management of Innovation The author, Peter Bamfield, is now working as a consultant. Due to his long experience in the chemical industry, he was elected President of the Royal Society of Chemistry's Industrial Affairs Division, and thus has a profound first-hand view of staff, companies and organizations in and around the industry. This third edition has been revised and updated to take into account global developments and recent changes in regulatory affairs.

Chemical Engineering in the Pharmaceutical Industry

Author : Mary T. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1119285518
Total Pages : 688 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-01 with total page 688 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.

Business Process Management within Chemical and Pharmaceutical Industries

Author : Guido Grüne
Publisher : Springer Science & Business Media
ISBN 13 : 3642117171
Total Pages : 175 pages
Book Rating : 4.6/5 (421 download)

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Book Synopsis Business Process Management within Chemical and Pharmaceutical Industries by : Guido Grüne

Download or read book Business Process Management within Chemical and Pharmaceutical Industries written by Guido Grüne and published by Springer Science & Business Media. This book was released on 2013-11-08 with total page 175 pages. Available in PDF, EPUB and Kindle. Book excerpt: As business processes are crucial success factors for companies, software-based Business Process Management (BPM) is becoming more and more important. In this area SAP, the market leader for enterprise application software, has already gathered substantial experience. For the characterization, modeling and especially the optimization of business processes, SAP’s consultants use their own BPM approach. In addition to their considerable methodological know-how, the consultants’ profound knowledge of the industries facilitates the focus on core and business-critical processes. This book examines the current market situation, as well as the specific challenges and trends for the chemical and pharmaceutical industries. It also explains business process management basics and the specific SAP Consulting methodology, before illustrating the use of such methods and procedures with sample industry-specific core business processes. With the help of these examples from the chemical and pharmaceutical industries, SAP Consulting provides methodological guidelines on how Business Process Management can be used in practice to optimize business processes and make adjustments in response to constantly changing economic and environmental factors.