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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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

Contamination Control in Healthcare Product Manufacturing, Volume 2, edited by Russell E. Madsen and Jeanne Moldenhauer, Volume 2 addresses some microbial control issues as well as other types of contamination. These valuable chapters will provide a great deal of information in your arsenal for contamination …

Volume 3 discusses extensive subjects related to water considerations and also includes invaluable advice regarding ventilation systems, the microbiology laboratory, mold, microaerophillics, Burholderia cepacia, a life cycle approach to cleaning validation, extensive coverage of risk management with …

The application of risk management to the processes within the healthcare industry is not just good practice, but an essential must do for any competitive and compliant enterprise. Whereas the ICH Q9 guideline "Quality Risk Management" describes the fundamental concepts, additional information is needed …

Training of new employees in a pharmaceutical company almost always includes instilling a 'healthy fear' of inspections conducted by regulatory agencies. Most, if not all, countries in the world have governmental agencies responsible for the safety and efficacy of the medicines manufactured, sold, and …

The book contains many new practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions during planning, execution and post-implementation changes for all projects. This book is centered on what "sufficient performance" and "suitable for …