Summary This article provides an advisory approach regarding how to avoid an FDA Warning Letter following the receipt of a significant Form FDA 483. The focus is on the 483 response as it applies to GCP but can be applied to the response to the Warning Letter itself as well as a wider scope of GXP (GMP, GLP, GCP) inspection and audit responses. Copyright © 2011 John Wiley & Sons, Ltd.

This article focuses on preparation of a Clinical Investigator site, immediately prior to FDA inspection. This process can be driven by either the Sponsor or the Clinical Investigator site, but ideally it is a combined approach involving both parties, as well as the Contract Research Organization (CRO) if one is used. This ‘last minute’ preparation task can arise at any time whereby there is some prior FDA notice of an impending inspection, which often occurs after a clinical trial has been completed, the marketing application has been submitted, the research site is notified directly and/or the Sponsor is asked for additional information concerning specific sites. The author believes that this is not the time for a Quality Assurance (QA) audit but rather a management and organizational task if intent is to prepare the research site for immediate inspection. Time can most effectively be used assuring that all records are organized, available, and instructing sites on how to effectively manage the inspectional process. Copyright © 2010 John Wiley & Sons, Ltd.

AbstractThis article describes a process‐driven approach to the conduct of a Good Clinical Practice (GCP) audit at a clinical investigator site and to the assessment of systemic GCP compliance in just a few days with little or no background information. The technique involves looking at the site and resulting observations from a system‐related point of view, with the primary goal of finding flaws in methods of operation as opposed to looking for isolated errors. Then, expanding the impact of corrective actions to the maximum extent (i.e. to all systemic flaws). To put it simply, it is a process‐driven approach with the ultimate goal of getting the GCP system under satisfactory control. Copyright © 2008 John Wiley & Sons, Ltd.

Quality assurance (QA) is an independent ongoing process that should begin before an operation starts, continue while it is ongoing and after it concludes. While there are some good reasons to conduct QA audits after a clinical research trial has ended, the most cost effective quality measures must be taken prior to study start up with audits conducted early enough in the process to achieve maximum dynamic impact. Copyright © 2005 John Wiley & Sons, Ltd.

Form FDA (US Food and Drug Administration) 1572 completions and revisions generate a lot of paperwork for the pharmaceutical industry. Some of this is necessary but time can be saved and quality can be enhanced by a careful examination of what is actually required by regulation, and by understanding the real purpose of this form. Copyright © 2005 John Wiley & Sons, Ltd.

The current article is focused on the start up, design, and operation of a new clinical quality assurance unit or the restructuring of an existing one, and is intended to provide a management overview. General information is provided on appropriate company structure, leadership, staffing & evaluations, operations, standard operating procedures, useful information technology tools, as well as a general approach to compliance. References serve to provide additional details on many of these topics. Copyright © 2004 John Wiley & Sons, Ltd.

There are some unique considerations involved with the management and direction of a Quality Assurance (QA) auditing operation in both government and industry. An adequate understanding of not only the technical but also the unique behavioral dimensions of this profession are essential to effective operation and management. Copyright © 2003 John Wiley & Sons, Ltd.

AbstractClinical quality assurance (CQA) auditing of Phase II trials may help eliminate potential problems before they occur by providing valuable quality input before pivotal Phase III trials are undertaken. CQA auditing of Phase II trials can affect critical elements of design regarding Phase III protocols, and may be extremely useful in the early evaluation of vendors prior to investing in Phase III research. Copyright © 2003 John Wiley & Sons, Ltd.

AbstractMany CQA (clinical quality assurance) units were just being formed in the United States in the early 1980s, but are now commonly recognized components of Quality Assurance. CQA units operate in a unique environment when compared to GMP (good manufacturing practice) and GLP (good laboratory practice) units, and have vast responsibilities with regard to the magnitude and constantly changing nature of the clinical research activities they serve. The uniqueness and enormity of this task demands strategically planned activities that are designed to maximize the benefit of each CQA professional on staff. A number of methods are discussed in this article. Increased focus will deliver CQA into a new era of high impact. If properly focused and directed, CQA can serve as a small fulcrum to leverage big change in clinical research. This change is not limited to improved GCP compliance and quality, but can significantly improve company efficiency and profitability as well. Copyright © 2003 John Wiley & Sons, Ltd.