FDA Inspections: From Site Preparation to Response

Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.

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About this Course

Being ready for an FDA inspection requires coordination, organization, and preparation by investigators, research sites, sponsor/CROs, and IRBs. This course prepares investigators and sites for an FDA Bioresearch Monitoring Program (BIMO) inspection by reviewing the concrete steps to take before, during, and after the inspection.

The FDA Inspections course explains the inspection process and terminology, and provides strategies to prepare for an inspection including the review of regulatory guidance and manuals (such as the Compliance Program Guidance Manual [CPGM]), actively preparing the study team, and performing mock inspections. Reviews the importance of the Form FDA 482 and how to coordinate and communicate during an inspection as well as next steps and strategies for responding to a Form FDA 483. The course discusses how to create a CAPA plan to address findings.

Language Availability: English

Suggested Audiences: Clinical Investigators, Key Study Personnel, Principal Investigators, Research Managers, Research Site Representatives, Researchers, Sponsors/CROs, Sub-investigators

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person

Demo Instructions

Course Content

Overview of the FDA Inspection Process

Describes the principles of routine and for-cause FDA BIMO inspections. It reviews the CPGM for clinical investigator inspections and defines the clinical site team’s key roles and responsibilities during an inspection. This module also discusses the FDA Part 11 inspection program and topics that may be reviewed during inspections.

Recommended Use: Required
ID (Language): 20037 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix; Melissa Byrn, MS, MBE - University of Chicago

What to Expect During an FDA Inspection of a Clinical Site

Describes the general flow of an inspection from the time of initial contact through the exit meeting and follow up. Discusses strategies to facilitate response to FDA field investigators’ questions and observations during the inspection.

Recommended Use: Required
ID (Language): 20038 (English)
Author(s): Karen Christianson, RN, BSN - HRP Consulting Group

Preparing Your Clinical Site for FDA Inspections

Discusses how investigators can identify the most common findings from FDA inspections to prepare their site. Provides an overview of strategies to avoid the most frequently cited deficiencies from common FDA observations, including preparing the study team, early formation of an FDA inspection management team at the site, performing mock inspections, organizing files to recognize potential findings, and how to use CAPA plans to address systemic problems from practice inspections.

Recommended Use: Required
ID (Language): 20039 (English)
Author(s): Diane Paul, MS, RN - Drug Development Associates, LLC

Proper Site Conduct During the FDA Inspection

Covers types of organizational structures, proper site conduct during an inspection, questions FDA field investigators frequently ask, and ways to respond to findings and concerns during the inspection. Discusses development of a communication plan for the study team as well as appropriate conduct with field investigators during the inspection.

Recommended Use: Required
ID (Language): 20040 (English)
Author(s): Donna Evans, MS - Moffitt Cancer Center

Overview of Inspection Findings

Provides an overview of inspection findings, describing: the FDA Inspection classification, FDA Form 483 (Inspectional Observations) content and purpose, and the FDA warning letter. This module also discusses developing CAPA plans to respond to findings from warning letters and improve conduct of clinical research.

Recommended Use: Required
ID (Language): 20041 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix; Melissa Byrn, MS, MBE - University of Chicago

After the Inspection: Responding to Findings and Classifications

Identifies different classifications from an FDA inspection and describes how to respond appropriately. Goes in-depth on defining the CAPA process, creating good CAPA plans, and strategies for CAPA success. Reviews trends in FDA Official Action Indicated (OAI) classifications and associated common 483 findings.

Recommended Use: Required
ID (Language): 20042 (English)
Author(s): Susan Leister, BS, MBA, PhD, CQA, CSSBB - Technical Resources International, Inc. and University of Phoenix

FAQs

Who should take the FDA Inspections course?

This course is designed to prepare a site and researchers for an FDA inspection by reviewing the concrete steps to take before, during, and after the inspection. Because FDA inspections can be announced or unannounced, and can be for-cause or routine, it is important to prepare in advance.

This course is meant for individuals conducting FDA-regulated investigations of drugs, biologics, or devices, and therefore who will be involved in a clinical investigator and site inspection – including the investigators, clinical research coordinators, key study personnel, and others at the site.

This course can be used for professional development of investigators and key study personnel to supplement their basic human subjects research and GCP training.

How does this FDA Inspections course fit in with other CITI Program courses like human subjects research or good clinical practice (GCP) training?

This course supplements the basic human subjects research and GCP courses by providing specific, investigator and site-focused training on the topic of FDA inspections. It is not meant to replace other CITI Program courses.

How long does it take to complete the FDA Inspections course?

This course consists of six modules. Each module contains detailed content and quiz as well as images, supplemental materials (such as a downloadable example checklist), and case studies (when appropriate).

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. However, modules are each designed to take about 30 to 45 minutes to complete, which means the entire FDA Inspections course could take about three to four hours to complete.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

How frequently should learners take this course?

This course is designed to be taken to help individuals prepare for and respond to an FDA inspection. This course could be taken at any time during the FDA inspection process of the clinical investigator to help prepare and train the research team.

We recommend that learners complete this course at least once every three years if they are participating in FDA-regulated research or may be involved in an FDA inspection (for example, clinical research support staff or organizational research compliance office administrators).

What are the standard recommendations for learner groups?

This course is designed to be completed in its entirety and sequentially.

A recommendation is to set all modules as “Required” for initial completion. This would help learners to understand the entire FDA inspection process.

What are the advantages of CITI Program’s FDA Inspections course?

This course provides specific, peer-reviewed training developed by a range of experts in clinical research. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for FDA inspection training.

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