CAPA in the Pharmaceutical and Biotech Industries: How to Implement an Effective Nine Step Program contains the most current information on how to implement, develop, and maintain an effective Corrective Action and Preventive Action (CAPA) and investigation program using a nine step closed-loop process approach for medical devices and pharmaceutical and biologic manufacturers, as well as any anyone who has to maintain a quality system.This book addresses how companies often make the mistake of fixing problems in their processes by revising procedures or, more commonly, by retraining employees that may or may not have caused the problem. This event-focused fix leads to the false assumption that the errors have been eradicated and will be prevented in the future. The reality is that the causes of the failure were never actually determined, therefore the same problem will recur over and over. CAPA is a complete system that collects information regarding existing and potential quality problems. It analyzes and investigates the issues to identify the root cause of nonconformities. It is not just a quick-fix, simple approach, it is a process and has to be understood throughout organizations. Provides an understanding of the principles and techniques involved in the effective implementation of a CAPA program, from the identification of the problem, to the verification of preventive action Emphasis is placed on the practical aspects of how to perform failure investigations and root cause analysis through the use of several types of methodologies, all explained in detail Provides effective methods to use with a Corrective Action system to help quality professionals identify costly issues and resolve them quickly and appropriately

Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen practices from auto sector won't work for pharmaceutical, medical device, and biotech organizations. Kaizen needs to be customized for these life science industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized for such industries. For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 250 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals NHP, medical devices, biotech and healthcare sectors, and felt it will be beneficial to share those techniques and experiences. In addition to explaining all the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device and biotech companies. This book will be most applicable to small to medium-size companies. It will demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech and all life sciences organizations, irrespective of their size or workplace culture. It will also provide practical and useful examples and case studies of Kaizen principles that can be executed at various levels across the organization as well as for yourself as an individual to further your personal career. And last but not the least, it will help to improve revenues and create a lasting profitable change by using Kaizen principles and techniques.

Business Development in the biotechnology and pharmaceutical industries accounts for over $5 billion in licensing deal value per year and much more than that in the value of mergers and acquisitions. Transactions range from licences to patented academic research, to product developments as licences, joint ventures and acquisition of intellectual property rights, and on to collaborations in development and marketing, locally or across the globe. Asset sales, mergers and corporate takeovers are also a part of the business development remit. The scope of the job can be immense, spanning the life-cycle of products from the earliest levels of research to the disposal of residual marketing rights, involving legal regulatory manufacturing, clinical development, sales and marketing and financial aspects. The knowledge and skills required of practitioners must be similarly broad, yet the availability of information for developing a career in business development is sparse. Martin Austin's highly practical guide spans the complete process and is based on his 30 years of experience in the industry and the well-established training programme that he has developed and delivers to pharmaceutical executives from across the world.

With the appearance of methods for the sequencing of genomes and less expensive next generation sequencing methods, we face rapid advancements of the -omics technologies and plant biology studies: reverse and forward genetics, functional genomics, transcriptomics, proteomics, metabolomics, the movement at distance of effectors and structural biology. From plant genomics to plant biotechnology reviews the recent advancements in the post-genomic era, discussing how different varieties respond to abiotic and biotic stresses, understanding the epigenetic control and epigenetic memory, the roles of non-coding RNAs, applicative uses of RNA silencing and RNA interference in plant physiology and in experimental transgenics and plants modified to specific aims. In the forthcoming years these advancements will support the production of plant varieties better suited to resist biotic and abiotic stresses, for food and non-food applications. This book covers these issues, showing how such technologies are influencing the plant field in sectors such as the selection of plant varieties and plant breeding, selection of optimum agronomic traits, stress-resistant varieties, improvement of plant fitness, improving crop yield, and non-food applications in the knowledge based bio-economy. Discusses a broad range of applications: the examples originate from a variety of sectors (including in field studies, breeding, RNA regulation, pharmaceuticals and biotech) and a variety of scientific areas (such as bioinformatics, -omics sciences, epigenetics, and the agro-industry) Provides a unique perspective on work normally performed 'behind closed doors'. As such, it presents an opportunity for those within the field to learn from each other, and for those on the 'outside' to see how different groups have approached key problems Highlights the criteria used to compare and assess different approaches to solving problems. Shows the thinking process, practical limitations and any other considerations, aiding in the understanding of a deeper approach

Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products

From a managerial perspective, the biopharmaceutical industry represents a competitive, fast-changing, intellectually-powered, innovation-driven sector. Many management scholars have studied this discontinuous era to make sense of strategic behavior and the cognition of firms and top managers. A past look at the biopharmaceutical industry provides answers to questions that most managers have. For example, what options do you have and what actions do you take when new firms enter your industry? In the 1970s, new biotechnology firms, funded by venture capitalists, appeared in the pharmaceutical industry with new knowledge. Successful pharmaceutical firms decided to collaborate with the new entrants and forge relationships to develop and create new, biotechnology engineered drugs. Thus, the addition of new biotechnology firms ushered in a new business model based on strategic alliances. Strategic alliances have now become an industrial norm called open innovation. The author looks at the historical path of the biopharmaceutical industry, particularly in the United States. While the pharmaceutical industry’s main contributions to society are substantial, there are pressing challenges the industry must face, such as an increase in infectious disease outbreaks or the global aging population, which require new types of care, additionally, mental health care and prescription painkiller addiction are persistent issues with economic repercussions to both federal and local governments. This book presents a holistic view of the biopharmaceutical industry, putting it in a historical context. It will best serve those who are eager to learn about this dynamic, fast-evolving industry and who would like to tackle current biopharmaceutical industry issues in the United States and be prepared for future industry challenges.

A Self help book for Quality and Compliance for Quality professionals in the Pharmaceutical and Medical device industries