Bookstore Search

The past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines for environmental control. Unfortunately, the requirements are not equivalent among documents and nations. The Environmental Monitoring series edited by …

Sale - 20% off! Original Price US$800 PDA Member, US$1,000 Nonmember, US$700 Government Sale prices are already displayed and will be reflected during checkoutThe past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines …

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 checkoutThe past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines …

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 volume adds to the wealth of knowledge provided in the previous volumes by addressing several important issues not previously discussed in …

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 checkoutAn essential addition to this valuable series, Volume 6 offers current information about numerous subjects including E.M. computerized systems, …

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 is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental …

The Barr Decision (Barr, 1993) forever changed how pharmaceutical companies look at data that is out-of-specification (OOS). Following issue of this legal decision, many companies and regulators worked to determine how this decision affects microbiological test results.Microbial Risk and …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$210 Government Sale prices are already displayed and will be reflected during checkoutThe Bio/Pharmaceutical industry is at an interesting crossroads regarding the use of electronic technologies in laboratories. Laboratory management …

This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish …

Sale! Original Price US$535 PDA Member, US$670 Nonmember, US$465 Government Sale prices are already displayed and will be reflected during checkout"Cleaning and Cleaning Validation" is a series of volumes containing current knowledge and approaches to cleaning and cleaning validation of …

Clearance Sale! Original Price US$375 PDA Member, US$465 Nonmember, US$250 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. Modeled on …

In honor of Jack Lysfjord who passed away on March 14, 2024, this bundle is 50% off until the end of the year. PDA remembers Jack Lysfjord as an expert in the field of Aseptic Processsing and he will be greatly missed. To learn more about Jack please click here …

Sale - 20% off! Original Price US$225 PDA Member, US$279 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutSince the advent of the Parenteral Drug Association's technical report on the validation of moist heat sterilization processes (PDA, 2007), it has …

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 …

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 …

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 …

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 …

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 …

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 …

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 …