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In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents. The information it provides on conducting investigations that will be acceptable to regulatory investigators will …

This timely and informative text discusses aspects of contamination control in cleanrooms seldom described in detail in the literature. The increasing number of warning letters, product recalls and 483 observations related to both particulate and microbial contamination indicates that contamination control …

This second of two volumes details how pharmaceutical and healthcare manufacturers have ben embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures …

This second of two volumes details how pharmaceutical and healthcare manufacturers have ben embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures …

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies …

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies …

From this book, you will learn a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. You will also get access to templates the authors have used as training tools for more …

From this book, you will learn a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. You will also get access to templates the authors have used as training tools for more …

Are you prepared for recalls relating to pharmaceutical and healthcare medications and medical devices? This book contains details about recalls from start to finish, including advice on how to handle a recall and, more importantly, how they can be avoided. Read about regulatory perspectives, trends …

The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.In addition to the Warning Letter summaries there is discussion of …

The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.In addition to the Warning Letter summaries there is discussion of …

Following an introduction to the subject of Good Distribution Practice (GDP), in the second volume, dive into supply-chain risk mitigation, serialization, and packaging as it relates to risk assessments. This text and its companion Volume 1 will help drive down costs and improve efficiency.Available …

Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the requirements of Qualified Persons and Responsible Persons in …

The handbook on Contamination Prevention for Nonsterile Pharmaceutical Manufacturing offers guide-lines for best practices to be deployed within a manufacturing facility. It explains where the most common microbiological risks to nonsterile manufacturing reside and how to prevent contamination in the …

Effective Implementation of Audit Programs provides current perspectives on informal and formal audits.Written by Miguel Montalvo, who has more than 32 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities, this book applies …

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 …

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 …

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! 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 …