ISO 14001 Environmental Certification Step by Step: Revised Edition

The do-it-yourself manual, with steps to success and simple explanatory notes, designed for real companies. ISO 14001 Environmental Certification Step by Step has been written with smaller companies especially in mind.

Dr. A.J. Edwards explains how to achieve the ISO 14001 standard aided by resources freely available from the accompanying website, including a sample manual and detailed sample registers and procedures. Together, these provide a quick and straightforward guide to achieving the requirements of ISO 14001 Environmental Certification.

This revised edition has been updated to cover the latest developments in the interpretation of the standard, plus changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), Control of Pollution regulations, Dangerous Substances and Explosive Atmospheres Regulations, Landfill charges, Pollution Prevention and Control, and Asbestos Regulations. In addition, the new ISO 19011:2002 standard for auditing is reflected in the book, as are approaches to phased introduction of ISO 14001.

Many organisations working towards ISO 14001 already possess ISO 9000 registration, or choose to achieve ISO 14001 and ISO 9000 simultaneously as an integrated system.To prevent duplication, ISO 14001 Environmental Certification Step by Step includes cross-referencing of ISO 14001 requirements to the relevant procedures in the Quality System.

* A do-it-yourself manual, with steps to success and simple explanatory notes
* Revised and updated to cover developments in the interpretation of the standard, changes in related legislation, such as the EU's Eco-Management and Audit Scheme (EMAS), new standards and standards
* Supported by downloadable forms and procedures

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HVAC Systems and Components Handbook

With this authoritative reference at hand, engineers and technicians will gain full knowledge of each component in today Õs complex heating, ventilating, and air conditioning systems. Completely revised and fully updated, this second edition of a widely used working tool offers: Analyses of today Õs most efficient, most trouble-free systems ... Details on todays highly advanced components ... Ways to achieve economy and efficiency in design ... clear explanations of the environmental impact of HVAC design ... Information on meeting key codes and standards. Featuring contributions from the top companies in HVAC technology ÑYork, Allied Signal, Honeywell, and SverdrupÑthe Handbook is an ideal source of reliable and timely information and advice on HVAC systems and components.

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Clinical Drug Trials and Tribulations, Second Edition

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on… · international regulation and deregulation · venture capitalist investment · the IND process · informed consent · changes in manufacturing and updated and extended coverage of… · pediatric drug trial design · the advantages and disadvantages of orphan drug designations · the maximization of package inserts for marketing · post approval safety surveillance · withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

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http://rapidshare.com/files/72560327/Clinical_DTrials_Tribulations_SE.zip

SAS Programming in the Pharmaceutical Industry

At last! A real-world reference guide for clinical trial SAS programming, packed with solutions that programmers can apply to their day-to-day problems. Discover key techniques and tools available within Base SAS (including the macro language and PROC SQL), SAS/GRAPH, and SAS/STAT that can be used to resolve many common issues in working with clinical trial data. Organized to reflect the statistical programmer's work flow, this user-friendly text begins with an introduction to the working environment, then presents chapters on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. Valuable plug-and-play programming examples are provided throughout. Whether you're a novice seeking an introduction to SAS programming for the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, you'll find a wealth of practical suggestions to help you sharpen your skills.

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http://rapidshare.com/files/72556053/SAS_Prog_Pharma_Ind.zip

Management of Data in Clinical Trials

A valuable new edition of the trusted, practical guide to managing data in clinical trials

Regardless of size, type, or complexity, accurate results for any clinical trial are ultimately determined by the quality of the collected data. Management of Data in Clinical Trials, Second Edition explores data management and trial organization as the keys to developing an accurate and reliable clinical trial. With a focus on the traditional aspects of data collection as well as recent advances in technology, this new edition provides a complete and accessible guide to the management structure of a clinical trial, from planning and development to design and analysis. Practical approaches that result in the collection of complete and timely data are also provided.

While maintaining a comprehensive overview of the knowledge and tools that are essential for the organization of a modern clinical trial, the author has expanded the topical coverage in the Second Edition to reflect the possible uses of recent advances in technology in the data collection process. In addition, the Second Edition discusses the impact of international regulations governing the conduct of clinical trials and provides guidelines on ensuring compliance with national requirements.

Newly featured topics include:
*The growing availability of "off-the-shelf" solutions for clinical trials
*Potential models for collaboration in the conduct of clinical trials between academia and the pharmaceutical industry
*The increasing use of the Internet in the collection of data and management of trials
*Regulatory requirements worldwide and compliance with the ICH Good Clinical Practice (GCP) Guidelines
*Development of Standard Operating Procedures for the conduct of clinical trials

Complete with chapter summaries that reinforce key points as well as over one hundred examples, Management of Data in Clinical Trials, Second Edition is an ideal resource for practitioners in the clinical research community who are involved in the development of clinical trials, including data managers, research associates, data coordinators, physicians, and statisticians. This book also serves as an excellent supplemental text for courses in clinical trials at both the undergraduate and graduate levels.

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Clinical Trials Risk Management

Focusing on the day-to-day needs of a clinical trials manager, this book explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations. After building a foundation of basic principles, the authors lead readers through specific methods for handling the risks characteristically encountered in clinical trials. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

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Enhancement in Drug Delivery

Enhancement in Drug Delivery offers an accessible compendium covering a wide spectrum of methods to enhance drug delivery and absorption by various routes of administration. Drawing from a number of disciplines, it gives students and practitioners in pharmaceutics, medicine, and health-related disciplines a much-needed guide to current practices. It also provides a starting place for those working on delivery systems for new drugs or seeking to improve current systems by drawing on means applied in other routes. Organized by routes of delivery, the book covers oral, rectal, buccal and sublingual, dermal and transdermal, ocular, vaginal and uterine, nasal and brain administrations.

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http://rapidshare.com/files/72329229/Enhance_Drug_Delivery.zip

Hplc and Ce Principles and Practice

HPLC and CE: Principles and Practice presents the latest information on the most powerful separation techniques available: high-performance liquid chromatography (HPLC) and capillary electrophoresis (CE). Fundamental theory, instrumentation, modes of operation, and optimization of separations are presented in a concise, non-technical style to help the user in choosing the appropriate technique quickly and accurately. Well- illustrated and containing convenientend-of-chapter summaries of the major concepts, the book provides in-depth coverage of trouble-shooting, improvement of resolution, data manipulation, selectivity, and sensitivity.
Graduate students, technicians, and researchers who must use separations with little or no background in analytical chemistry can overcome separation anxiety and get started in obtaining the best possible separations in minimal time. The book will alsobe useful to analytical chemists who need a better understanding of theory and processes.

Key Features
* Fully up-to-date information on both HPLC and CE includes troubleshooting and comparisons of the two techniques
* Applicable to a wide variety of separation problems
* Covers basic concepts governing any separation as well as instrumentation and how to use it
* Helps the user to obtain optimal resolution in minimal time
* Contains information on special procedures such as chiral separations, affinity chromatography, and sample preparation
* Includes information on upcoming trends such as miniaturization
* Major concepts in each chapter are organized to allow access to information easily and quickly
* Contains practical bibliography for accessing the literature

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http://rapidshare.com/files/71222545/Hplc_Ce_Prin_Pract.zip

New Drug Development: Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics

Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than forty respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.

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http://rapidshare.com/files/71180729/New_Drug_Development.zip

Pharmaceutical Process Validation: An International Third Edition

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

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http://rapidshare.com/files/71178252/Pharmaceutical_Process_Validation_TE.zip

Drugs and Controlled Substances Information for Students

Drugs and Controlled Substances: Information for Students is a medical reference product designed to inform and educate readers about a wide variety of drugs and controlled substances. The Gale Group believes the product to be comprehensive, but not necessarily definitive. It is intended to supplement, not replace, consultation with a physician or other health care practitioner. While the Gale Group has made substantial efforts to provide information that is accurate, comprehensive, and up-to-date, the Gale Group makes no representations or warranties of any kind, including without limitation, warranties of merchantability or fitnessfor a particular purpose, nor does it guarantee the accuracy, comprehensiveness, or timeliness of the information contained in this product. Readers should be aware that the universe of medical knowledge is constantly growing and changing, and that differences of medical opinion exist among authorities. Readers are also advised to seek professional diagnosis and treatment of any possible substance abuse problem, and to discuss information obtained from this book with their health care provider.

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http://rapidshare.com/files/123264992/Dcsis.zip

Advanced Pharmaceutical Solids

This extensive reference/text explores the principles, instrumentation, processes, and programs of pharmaceutical solid science as well as new aspects on one-component systems, micromeritics, polymorphism, solid-state stability, cohesion, powder flow, blending, single- unit sustained release, and tablet coating. Reveals unique approaches in pharmaceutical solid science not previously published in any other text! Providing current data on crystallization, dissolution from particles and polydisperse populations, powder volumes and densities, comminution, wet granulation, and hard-shell capsules, Advanced Pharmaceutical Solids · describes moisture isotherms with crystalline solids · documents the effects of moisture on solid-state stability · highlights tablet physics and principles · explains sustained release by microencapsulation · presents prediction equations for solubility in binary solvents · discusses particle sizes and diameters · identifies Brunauer, Emmett, and Teller Isotherms · and more! Considering properties of solids, permeamitry and gas absorption methods, amorphates, and purification by pH-change precipitation, Advanced Pharmaceutical Solids is an essential reference for pharmacists; pharmaceutical scientists; medicinal, physical, surface, colloid, and analytical chemists and biochemists; and an effective text for upper-level undergraduate and graduate students in these disciplines.

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http://rapidshare.com/files/69808903/Adv_Pharma_Solid.zip

Handbook of Industrial Crystallization, Second Edition (Purification of Laboratory Chemicals)

Crystallization is an important separation and purification process used in industries ranging from bulk commodity chemicals to specialty chemicals and pharmaceuticals. In recent years, a number of environmental applications have also come to rely on crystallization in waste treatment and recycling processes.

The authors provide an introduction to the field of newcomers and a reference to those involved in the various aspects of industrial crystallization. It is a complete volume covering all aspects of industrial crystallization, including material related to both fundamentals and applications. This new edition presents detailed material on crystallization of biomolecules, precipitation, impurity-crystal interactions, solubility, and design.

Provides an ideal introduction for industrial crystallization newcomers
Serves as a worthwhile reference to anyone involved in the field
Covers all aspects of industrial crystallization in a single, complete volume

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http://rapidshare.com/files/69388426/Industrial_Crystallization.zip

Statistical Thinking for Non Statisticians in Drug Regulation

Written by a well-known lecturer and consultant to the pharmaceutical industry, this book focuses on the pharmaceutical non-statistician working within a very strict regulatory environment. Statistical Thinking for Clinical Trials in Drug Regulation presents the concepts and statistical thinking behind medical studies with a direct connection to the regulatory environment so that readers can be clear where the statistical methodology fits in with industry requirements. Pharmaceutical-related examples are used throughout to set the information in context. As a result, this book provides a detailed overview of the statistical aspects of the design, conduct, analysis and presentation of data from clinical trials within drug regulation.

Statistical Thinking for Clinical Trials in Drug Regulation:

• Assists pharmaceutical personnel in communicating effectively with statisticians using statistical language
• Improves the ability to read and understand statistical methodology in papers and reports and to critically appraise that methodology
• Helps to understand the statistical aspects of the regulatory framework better quoting extensively from regulatory guidelines issued by the EMEA (European Medicines Evaluation Agency), ICH (International Committee on Harmonization and the FDA (Food and Drug Administration)

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Handbook for Critical Cleaning: Aqueous, Solvent, Advanced Processes,Surface Preparation, and Contamination Control

With all the cleaning approaches available, how do you choose which one is best for your needs? Components manufacturers wonder which will provide a competitive edge. Chemists and engineers worry about the effect of any process modification on a critical component or on the stability of an irreplaceable antique. There is no silver bullet, no magic drop-in solution. The best approach is application specific and often location specific. Handbook for Critical Cleaning provides the tools you need to select the best approach in a rapidly changing world. Rigorous in its treatment of technical issues, broad in scope, and clearly written, the book includes cleaning agent options, cleaning systems/chemical and equipment integration, contamination control, cleanliness standards, analytical testing, process selection, implementation, and maintenance, specific applications areas, and regulatory considerations and outlook. Cleaning, which was once a simple decision among a few cleaning agents and types of equipment, is now recognized as a major factor in process control and product improvement. Choosing the best process involves an understanding of chemistry, engineering, safety and regulatory requirements, as well as a realistic assessment of the strengths and limitations of the local workforce. Handbook for Critical Cleaning shows you not only what processes are available and how to evaluate them, but how to customize cleaning procedures to meet your needs.

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http://rapidshare.com/files/68916761/Handbook_for_Critical_Cleaning.zip

Validation and Qualification in Analytical Laboratories, Second Edition

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.

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http://rapidshare.com/files/67987349/Vali_Quali_Anal_Lab.zip

Pharmaceutical Guidelines

Common Technical Document:

ASEAN
ICH

GMP -Drug Product:

INDIA
PIC
USFDA
WHO

GMP-Drug substances:

ICH
PIC
USFDA
WHO

ICH Guidelines:

Efficacy
Multidisciplinary
Quality
Safety

Regulatory Audits:

PIC
WHO

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Water Quality Control Handbook, Second Edition

Capitalize on the Latest Design and Operating Innovations for Achieving Peak Performance in Any Wastewater Treatment Plant

Wastewater treatment professionals can turn to the updated Second Edition of Water Quality Control Handbook for cutting-edge information on designing and operating systems used to treat wastewater from industrial and domestic sources. This state-of-the-art guide explores design innovations, equipment selection, treatment processes, new regulations, and operating methods for achieving peak performance in all kinds of wastewater treatment facilities.

Noted pollution control expert E. Roberts Alley examines breakthroughs that are improving current wastewater treatment practice. He covers the optimization of activated sludge wastewater treatment through cation control …pH control for quickly varying pH levels…and the use of separate activated sludge treatment units in series to efficiently treat a mixture of biodegradable and refractory organics. The author also discusses the design of activated sludge wetlands…new pollutant precipitation techniques…total nitrogen removal design…recommendations for reducing effluent toxicity to aquatic life…and much more. Filled with 650 illustrations, charts, and tables, the Second Edition of Water Quality Control Handbook features:

• Expanded coverage of treatment systems for specific pollutants
• The latest water quality regulations
• New sections on wastewater treatment operations, new material on membrane treatment processes, and new developments in cost-saving treatment design methods

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Indoor Air Quality Handbook

* Tackles the complex environmental issue of Indoor Air Quality (IAQ) for industrial hygienists, HVAC engineers, architects and anyone else concerned with the air quality of interiors
* Infused with charts, tables, and all the major formulas and calculations necessary to monitor and characterize a particular environment
* Includes all relevant codes, standards and guidelines

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SalonOvations' Guide to Aromatherapy

This is a comprehensive training book for every beauty professional wanting to use aromatherapy in their treatment of their own clients.


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