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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 …

Clearance Sale! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutRapid microbiological methods have made amazing strides recently and this volume complements Dr. Miller's previous three volumes by offering …

Sale - 20% off! Original Price US$795 PDA Member, US$989 Nonmember, US$685 Government Sale prices are already displayed and will be reflected during checkoutBuy All 3 Volumes and Save 20% Microbiologists and management alike are working together to remove the perceived barriers to implementing RMM in …

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 …

The current compendial sterility test methodology has been fully harmonized for Europe, Japan and the United States for many years. In spite of having a fully harmonized test methodology, in reality, the test methodology is only effective in detecting gross contamination in a batch of product. Manufacturers …

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 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 …

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 …

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 …

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 …

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 …

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 …

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 …