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Validating Enterprise Systems: A Practical Guide (single user digital version)
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Sale - 20% off! Original Price US$225 PDA Member, US$279 Nonmember, US$175 Government Sale prices are already displayed and will be reflected during checkoutHere is a book that one peer reviewer called "brilliant." Written by a well-know subject matter expert, this book describes the latest tools, techniques … -
Laboratory Design: Establishing the Facility and Management Structure (single user digital version)
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This book focuses on the design procedures that minimize the likelihood of error. It also explains how to design the laboratory facility to maximize the ability of staff to get their work done in an efficient and effective manner by describing the best practices available for design planning, technical … -
Validation by Design: The Statistical Handbook for Pharmaceutical Process Validation (single user digital version)
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This book offers an overview of the statistical issues expressed and implied in the U.S. FDA`s Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008. The need for this book is illustrated by the many inquires the author receives about how to use and implement … -
Biofilm Control in Drug Manufacturing (single user digital version)
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This book provides guidance in preventing and controlling Biofilm contamination in pharmaceutical and biopharmaceutical processing. Twelve chapters contributor by global experts and useful appendices cover topics such as the Contamination Control by Design Model, the impact of biofilms on pharmaceutical … -
Sterility Testing of Pharmaceutical Products (single user digital version)
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Sale - 20% off! Original Price US$240 PDA Member, US$299 Nonmember, US$210 Government Sale prices are already displayed and will be reflected during checkoutThe central argument of the book is that control of the process and environmental control are considerably more important guarantors of sterility … -
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (single user digital version)
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Sale - 20% off! Original Price US$255 PDA Member, US$319 Nonmember, US$160 Government Sale prices are already displayed and will be reflected during checkoutRisk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple, begins with history, definitions, how we think about risks … -
The Bacterial Endotoxins Test: A Practical Guide (single user digital version)
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This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical and compliant approach to the execution and use of BET. Full of sensible technological and compliance advice … -
Quality By Design: Putting Theory Into Practice (single user digital version)
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Sale! Original Price US$210 PDA Member, US$259 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThis book is written with all stakeholders in mind; the regulatory agencies and the healthcare industry, including their suppliers. As the process of … -
Pharmaceutical Outsourcing: Quality Management and Project Delivery (single user digital version)
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Intended to set forth and explore the best practices for contract organizations from various perspectives: the contract organization, the contracting organization and the regulators.There has been a significant amount of activity and growth in contract operations. Many companies are looking to contract … -
Technology and Knowledge Transfer: Keys to Successful Implementation and Management (single user digital version)
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Written by global subject matter experts, this book offers the practical experience needed to obtain a competitive edge. The successful technology transfer from research and development to the commercial production site is a critical process in the development and launch of a new medicinal product. An … -
Cleanroom Microbiology (single user digital version)
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While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled … -
PDA Technical Report No. 54-4, (TR 54-4) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Mfg of Biotechnological Bulk Drug Substances (single user digital version)
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The goal of Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances is to provide detailed examples of characteristic operations and case studies that demonstrate the value of implementing QRM to effectively manage risks during manufacturing of biotechnological bulk drug … -
Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes (single user digital version)
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Sale - 20% off! Original Price US$210 PDA Member, US$259 Nonmember, US$170 Government Sale prices are already displayed and will be reflected during checkoutThe goal of Lynn and Joyce Torbeck's book, Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes, is to … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volumes 1, 2 & 3 (single user digital version)
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Sale - 20% off! Original Price US$635 PDA Member, US$790 Nonmember, US$435 Government Sale prices are already displayed and will be reflected during checkoutThe three volumes Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and … -
Cold Chain Chronicles: A practitioners outside-the-box perspectives on the importance of temperature-sensitive drug stewardship (single user digital version)
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Sale - 20% off! Original Price US$210 PDA Member, US$259 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutThis book is quite different from the typical prescriptive PDA/DHI "how-to" publication. Noted pharmaceutical cold-chain expert, Kevin … -
PDA Survey: 2014 PDA Process Validation Survey (single user digital version)
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This benchmarking survey was designed to solicit feedback on and industry status on the application of the principles established in the FDA Process Validation Guidance for Industry of 2011. The survey also investigated how companies are implementing the new lifecycle approach to process validation and … -
Environmental Monitoring: A Comprehensive Handbook, Volume 3 (single user digital version)
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Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThis book addresses current scientific, regulatory and technology environmental monitoring concerns for both aseptic processing and isolation … -
Environmental Monitoring: A Comprehensive Handbook, Volume 2 (single user digital version)
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Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application … -
Environmental Monitoring: A Comprehensive Handbook, Volume 1 (single user digital version)
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Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application … -
Contamination Control in Healthcare Product Manufacturing, Volumes 1, 2 & 3 (single user digital version)
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50 global subject matter experts share their broad experience in all aspects of healthcare product manufacturing contamination control in this three-volume set.The first volume of Contamination Control contained chapters that are predominantly centered on microbial issues. Volume 2 addresses some microbial …
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