HVAC Inspection Notes: Up to Code

Up to Code: HVAC Inspection Notes is an on-the-job “cliff notes” resource, packed with information that will save time and money while ensuring quality. To-do checklists, charts and tables with at-a-glance calculations, who’s-responsible-for-what info, and diagrams that clearly illustrate complicated information make it fast and easy for busy building professionals to do their jobs thoroughly and efficiently, and avoid costly mistakes. The books help building pros establish and meet inspection guidelines, and provide clients with schedules and specifications. Each of the Up to Code: Inspection Notes is focused on the IBC (International Building Code), the most widely adopted building code in North America. HVAC will also focus on information from the SMACNA Duct Manual. Each guide covers: Responsibility; Authority; Quality Control and Assurance; Plans and Specifications; Shop Drawings; Inspectors Daily Report; Pre-Construction Meeting; Equipment Proposal; Claims; Progress Schedules; Labor Enforcement; Storage of Materials; Contractor’s Payment; Rights-of-Way; Record Drawings; Project Turnover; Inspection Files; Recommended Equipment; Inspection; Safety.

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Development and Validation of Analytical Methods

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations.

The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.

Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples.

Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.

This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

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What is Packaging Design? (Essential Design Handbook)

Book Description:

"A thoughtful and thorough book with some inspiring work -- great for students and anyone taking their first steps into the world of packaging."

This is a highly visual, compact-format sourcebook, packed with top international packaging designers' contemporary work, accompanied by essays on the surrounding issues.

What Is Packaging Design? lays the foundations and professional guidelines for best practice when designing contemporary packaging. It opens with several short essays which define good packaging design and the issues faced by designers in this field. Design basics such as format, layout and typography are explored within the context of packaging design, taking into account genre-specific elements such as product information, branding, marketing and legislation.

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High Resolution NMR: Theory and Chemical Applications, 3rd Edition

High Resolution NMR provides a broad treatment of the principles and theory of nuclear magnetic resonance (NMR) as it is used in the chemical sciences. It is written at an "intermediate" level, with mathematics used to augment, rather than replace, clear verbal descriptions of the phenomena. The book is intended to allow a graduate student, advanced undergraduate, or researcher to understand NMR at a fundamental level, and to see illustrations of the applications of NMR to the determination of the structure of small organic molecules and macromolecules, including proteins. Emphasis is on the study of NMR in liquids, but the treatment also includes high resolution NMR in the solid state and the principles of NMR imaging and localized spectroscopy.

Careful attention is given to developing and interrelating four approaches - steady state energy levels, the rotating vector picture, the density matrix, and the product operator formalism. The presentation is based on the assumption that the reader has an acquaintance with the general principles of quantum mechanics, but no extensive background in quantum theory or proficiency in mathematics is required. Likewise, no previous background in NMR is assumed, since the book begins with a description of the basic physics, together with a brief account of the historical development of the field.
This third edition of High Resolution NMR preserves the "conversational" approach of the previous editions that has been well accepted as a teaching tool. However, more than half the material is new, and the remainder has been revised extensively. Problems are included to reinforce concepts in the book.

Key Features

* Uses mathematics to augment, not replace, verbal explanations
* Written in a clear and conversational style
* Follows the successful format and approach of two previous editions
* Revised and updated extensively--about 70 percent of the text is new
* Includes problems and references to additional reading at the end of each chapter

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International Pharmaceutical Registration

The increasing globalization of pharmaceutical markets and continuing consolidation within the pharmaceutical industry have highlighted the challenges of rapidly evolving regulatory requirements and created a much greater appreciation of the need for regulatory awareness throughout the industry. This book provides a practical overview and guide to the complexities of international pharmaceutical registration. With individual country chapters written by experts within that country drawn from regulatory authorities, international pharmaceutical companies, and regulatory consultants, the book comprehensively covers regulations across the globe.

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http://rapidshare.com/files/65008233/Inter_Pharma_Rreg.zip

Drug Information: A Guide for Pharmacists

This well-known guide teaches pharmacists and pharmacy students how to more effectively and efficiently research, interpret, utilize, organize, and distribute drug information.

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http://rapidshare.com/files/64286770/Drug_Info.zip

Modern Pharmaceutics

Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the pharmacodynamic and physicochemical factors influencing drug action through various routes of administration.

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http://rapidshare.com/files/63596960/Modern_Pharmaceutics.zip

Pharmaceutical Experimental Design

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development. Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design! Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental Design · offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other books · reviews screening designs for qualitative factors at different levels · presents designs for predictive models and their use in optimization · highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirability · discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transfer · details nonstandard designs and mixtures · analyzes factorial, D-optimal design, and offline quality assurance techniques · reveals how one experimental design evolves from another · and more! Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

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http://rapidshare.com/files/63384606/Pharma_Experim_Design.zip

Japanese Pharmacopoeia (Jp Xiv) (Pharmacopoeia of Japan)

• Publisher: Society of Japanese Pharmac
• Number Of Pages: 1357
• Publication Date: 2002-01
• Sales Rank: 3114417
• ISBN / ASIN: 4840806721
• EAN: 9784840806725
• Binding: Hardcover
• Manufacturer: Society of Japanese Pharmac
• Studio: Society of Japanese Pharmac

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Dictionary of Medical Acronyms & Abbreviations (5th Edition)

This best-selling portable resource provides authoritative definitions for all of the medical acronyms and abbreviations you can expect to encounter in medicine today. The new, 5th Edition features 10,000 completely new entries reflecting the most recent developments in health careincluding new clinical trials, new technologies, and new advances. Highlights include the latest virus nomenclature, computer technology, medical informatics, and molecular biology, along with more from the ever-expanding list of organizations and associations.

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http://rapidshare.com/files/62901388/DICTI__MEDICAL_ACRONYMS__ABBRE.zip

A Practical Approach to Water Conservation for Commercial and Industrial Facilities

Industry and commerce use vast amounts of water and in some parts of the world water is becoming a scarce commodity. We need to take more care in our future use of water, and this book is a 'best practice' manual for industrial and commercial users world-wide. It offers a practical account of the measures which can be taken to re-educate industrial and commercial users in the techniques of water saving and re-use anywhere in the world. The principles are covered in detail and supported by examples from specific industries and commercial operations. Author Mohan Seneviratne is Manager of Sydney Water's 'Every Drop Counts Business Program', which won the prestigious 2006 Stockholm Industry Water Award in recognition of how the utility is working in partnership with business, industry and government to help ensure the long-term sustainability of Sydneys water supply.

* VERY topical subject
* Based on Australian experience
* First book to cover this problem for industrial users

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This handbook attempts to select or define robust procedures that ensure the best use of resources and enable laboratories to generate consistent, reliable data. Written in concise, easy-to-read language and illustrated with worked examples, it is a guide to current best practice and establishes a control framework for the development and validation of laboratory-based analytical methods. Topics include samples and sampling, method selection, equipment calibration and qualification, method development and validation, evaluation of data and statistical approaches for method performance and comparison.

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http://rapidshare.com/files/62679858/Valid_Analytical_Methods.zip

Generic Drug Formulations

A selection of about 500 formulations of human and veterinary drugs are presented in this booklet. They have all been developed in the last 20 years in the Applications Laboratories of BASF AG and are in solid, liquid, and semi-solid form. However, emphasis is placed on tablets. Human and veterinary medicines have not been dealt with in separate chapters, because the technologies and excipients are the same.

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http://rapidshare.com/files/62246601/generic.zip

Practical Guide to the Care of the Medical Patient

If you need a practical, portable resource to get you through your internal medicine clerkship or residency, this book is the answer! It zeroes right in on the differential diagnoses, clinical findings, lab values, and treatment guidelines you need to diagnose and manage more than 225 disorders, signs, and symptoms...and makes them easy to access quickly! This 7th Edition covers 53 new differential diagnoses and 37 new topics...includes more color dermatology images...and features a more compact format for increased portability and ease of use.

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http://rapidshare.com/files/62225986/Care_of_the_Medical_Patient.zip

The Handbook of Patient Safety Compliance: A Practical Guide for Health Care Organizations

Written for virtually every professional and leader in the health care field, as well as students who are preparing for careers in health services delivery, this book presents a framework for developing a patient safety program, shows how best to examine events that do occur, and reveals how to ensure that appropriate corrective and preventative actions are reviewed for effectiveness. The book covers a comprehensive selection of topics including

• The link between patient safety and legal and regulatory compliance
• The role of accreditation and standard-setting organizations in patient safety
• Failure modes and effect analysis
• Voluntary and regulatory oversight of medical error
• Evidence-based outcomes and standards of care
• Creation and preservation of reports, data, and device evidence in medical error situations
• Claims management when dealing with patient safety events
• Full disclosure
• Patient safety in human research
• Managing confidentiality in the face of litigation
• Managing patient safety compliance through accountability-based credentialing for health care professionals
• Planning for the future

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http://rapidshare.com/files/62199078/Patient_Safety_Compliance.zip

Fundamentals of Preventive Maintenance

"Plant engineers and maintenance managers know from experience: All manufacturing equipment will break down, often at the worst possible moment. To survive in today's lean-and-mean manufacturing environment, companies must head off these breakdowns with a preventive-maintenance management program that is both systematic and flexible -- and geared toward minimizing downtime and maximizing equipment life. Fundamentals of Preventive Maintenance provides readers with an easy-to-follow, economically sensible maintenance and workorder management program. This results-driven guidebook outlines a 7-step process for designing and implementing the program, describing what needs to be done -- and why. Designed to transform an often unwieldy program into one that can be effectively managed, it provides hands-on techniques for: * Establishing critical scheduling protocols * Managing the daily workorder schedule * Developing and issuing preventive maintenance workorders * Monitoring the program and making improvements"

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http://rapidshare.com/files/62191563/Funda_Preventive_Main.zip

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

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Solving Problems with NMR Spectroscopy

Solving Problems with NMR Spectroscopy presents the basic principles and applications of NMR spectroscopy with only as much math as is necessary. It shows how to solve chemical structures with NMR by giving clear examples and solutions. This text will enable organic chemistry students to choose the most appropriate NMR techniques to solve specific structures. The problems to work and the discussion of their solutions and interpretations will help readers becomeproficient in the application of important, modern 1D and 2D NMR techniques to structural studies.

Key Features
* Presents the most important NMR techniques for structural determinations
* Offers a unique problem-solving approach
* Uses questions and problems, including discussions of their solutions and interpretations, to help readers grasp NMR
* Avoids extensive mathematical formulas
* Forewords by Nobel Prize winner Richard R. Ernst and Lloyd M. Jackman

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http://rapidshare.com/files/122299108/Sol_pro_nmspect.zip

Introduction to Computational Optimization Models for Production Planning in a Supply Chain

The book begins with an easy-to-read introduction to the concepts associated with the creation of optimization models for production planning. These concepts are then applied to well-known planning models, namely mrp and MRP II. From this foundation fairly sophisticated models for supply chain management are developed. Another unique feature is that models are developed with an eye toward implementation. In fact, there is a chapter that provides explicit examples of implementation of the basic models using a variety of popular, commercially available modeling languages. The new edition is updated and provides extensions.

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Mass Spectrometry and Genomic Analysis

The human genome project is set to revolutionise health care and medicine in the near future. The genetic make up of each individual gives clues as to the genetic factors that predispose one to a particular genetic disease. Single Nucleotide Polymorphisms (SNPs), single base changes in the nucleotide DNA sequence of individuals, are thought to be the main cause of genetic variation. By comparing patterns of SNP allele frequencies between disease affected and control populations, disease associated SNPs can be identified and potential disease gene(s) located. These types of study necessitate genotyping of thousands of SNPs which requires the use of powerful, high throughput, systems of analysis. Mass spectrometry is fast becoming the preferred technology for this type of high throughput analysis.

This book contains a collection of descriptions of some of the most outstanding advances in the field of mass spectrometry from which, I hope, the reader will be able to learn both the principles and the most up to date methods for its use in genomic analysis. It covers the general principles of the technologies and more in depth detailed descriptions for more academic reading and information.

Audience: Whether you are a student, a post-doctoral researcher or experienced MS user, this book will be a stimulating addition to the analytical arena of mass spectrometry and genomic analysis.

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http://rapidshare.com/files/61034481/Mass_Spectrometry_Genomic_Ana.zip

Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy (Practical Spectroscopy)

This book discusses the theory, instrumentation, validation, and implementation of near-infrared spectroscopy for pharmaceutical and medical applications. It showcases a diverse range of contemporary methods for the production, screening, and analysis of new drug products and pharmaceuticals. Presents current approaches in near-infrared spectroscopy (NIR) to monitor and control multiple phases of the drug manufacturing process.

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http://rapidshare.com/files/61031951/Pharma_Medi_Appli_Near-IRS.zip

Facilities Management Handbook, Third Edition

The world of facilities management has changed dramatically in recent years. From humble beginnings it is now a fully-fledged professional discipline cover a wide range of challenging roles that go right to the heart of business success.

The Facilities Management Handbook gives a complete and comprehensive guide to the different aspects of the Facility Manager's role, from compliance with health and safety law through risk management to getting the most out of buildings and space.

The Handbook provides checklists and practical guidance that ensures that the Facilities Manager can meet the increasingly complex demands of their profession.

* Wealth of information available in an easily accessible and readable format

* Enables managers to keep abreast of all key facts required in the day-to-day running of a business

* Offers a concise encyclopaedia on all facilities management issues, combining best practice tips with proactive legal advice

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http://rapidshare.com/files/60387028/Facilities_Management_Handbook.zip

Sterile Filtration: A Practical Approach

This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals. Addresses the complexities of globalizing redundancy in filtration! Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration · considers how many filters should be in the process stream · examines the existence of nanobacteria and viable but nonculturable organisms · covers pore size designations, distributions, architecture, and numbers · discusses the latest findings in bubble point and diffuse flow measurements · describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations · details wetting liquid, polymer, temperature, and water purity effects · explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases · outlines filter validation, requirements, and operational specifics · and more! Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.

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http://rapidshare.com/files/60374251/Sterile_filter.zip