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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 checkoutIn a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical …

Russ Madsen and Maik Jornitz have assembled fascinating stories from renowned industry practitioners who share their global work experiences to highlight root cause analysis and problem solving. Each story is written as a brief lesson that begins with a statement of the problem, the steps taken to analyze …

Visual inspection continues to be a critical step in the manufacture and release of high quality injectable medicines. There is limited specific guidance on inspection methods or acceptance criteria which has led to a wide range of industry practices. This diversity is also to be expected given the variety …

This publication presents the results of the PDA Quality Culture Metrics Surveys conducted in September and October 2014. Because similar questions were asked, two sets of results are shown side by side: those from the survey open to all PDA members and those from the survey sent to Heads of Quality …

Technical Report No. 71, Emerging Methods for Virus Detection describes and critically assesses methods currently used for the detection of potential adventitious viruses in biomedicinal products and their production processes. It also details new methods that have emerged as a result of technological …

PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified …

A trend is a series of events or data collected, generally over time, that has an established and expected pattern. The trend can be observed or it can be based on theoretical models. Any departure from the trend is then an unexpected out-of-trend event. It is atypical and begs for investigation. Trend …

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 …