Comprehensive Curriculum

Gain in-depth knowledge and practical skills in clinical research auditing

Expert Guidance

Learn from a prior U.S. FDA Investigator with years of experience in the field

Career Advancement

Boost your career prospects with a training certificate in quality assurance clinical research auditing

What you'll learn

Target Audience

Individuals with prior training and experience as a QA Auditor; Bachelor's degree minimum education requirement

Comprehensive Content

Embark on a transformative journey to become a Clinical Research Professional with our comprehensive course. Dive deep into the world of clinical research auditing and equip yourself with the necessary skills to excel in this dynamic field.

Active Learning

Our expert-led curriculum is designed to provide you with practical knowledge and hands-on experience, ensuring you are well-prepared for a successful career in quality assurance.

The syllabus

8 Chapters · 42 Lessons

  1. 1

    Introduction to Advanced Quality Assurance Auditor Training - Investigator Site Focused

    1. Course Welcome, Description, Outline, and Objectives Free preview
    2. Pretest Free preview
    3. (Included in full purchase)

      Importance of Audits in Clinical Research

    4. (Included in full purchase)

      Overview of Applicable Regulatory and Ethical Standards

    5. (Included in full purchase)

      Course Intro Reference Documents

    6. (Included in full purchase)

      Course Intro Knowledge Check

  2. 2

    Investigator Site Audits (ISAs) Overview

    1. (Included in full purchase)

      ISA Definition and Types of ISAs

    2. (Included in full purchase)

      Auditor Roles and Responsibilities During ISAs

    3. (Included in full purchase)

      ISA Purpose, Scope, and Objectives

    4. (Included in full purchase)

      ISAs Overview Reference Documents

    5. (Included in full purchase)

      ISAs Overview Knowledge Check

  3. 3

    ISA Preparation

    1. (Included in full purchase)

      Planning and Scheduling the ISA

    2. (Included in full purchase)

      Confirming Relevant System Access and Reviewing Prep Documentation

    3. (Included in full purchase)

      Developing Audit Strategies, Questions, and Checklists

    4. (Included in full purchase)

      ISA Preparation Reference Documents

    5. (Included in full purchase)

      ISA Preparation Exercise

    6. (Included in full purchase)

      ISA Prep Knowledge Check

  4. 4

    ISA Conduct

    1. (Included in full purchase)

      Implementing Audit Strategies and Techniques

    2. (Included in full purchase)

      Engaging with Site Staff During Audit Meetings and Interviews

    3. (Included in full purchase)

      Assessing the Investigator Site Facility

    4. (Included in full purchase)

      Reviewing Paper and Electronic Documentation

    5. (Included in full purchase)

      Common Investigator Site Pitfalls

    6. (Included in full purchase)

      ISA Conduct Reference Documents

    7. (Included in full purchase)

      ISA Conduct Case Study

    8. (Included in full purchase)

      ISA Conduct Exercise

    9. (Included in full purchase)

      ISA Conduct Knowledge Check

  5. 5

    ISA Reporting

    1. (Included in full purchase)

      Creating Audit Reports

    2. (Included in full purchase)

      Preparing Observations Statements and Evidence

    3. (Included in full purchase)

      ISA Reporting Reference Documents

    4. (Included in full purchase)

      ISA Reporting Case Study

    5. (Included in full purchase)

      ISA Reporting Knowledge Check

  6. 6

    ISA Follow-up, Including Audit Responses and Audit Closure

    1. (Included in full purchase)

      Following Up on Post Audit Actions

    2. (Included in full purchase)

      Assessing Audit Responses for Adequacy

    3. (Included in full purchase)

      Adequate Corrective and Preventive Action (CAPA) Plans

    4. (Included in full purchase)

      Closing the ISA

    5. (Included in full purchase)

      ISA Follow-up Reference Documents

    6. (Included in full purchase)

      ISA Follow-up Case Study

    7. (Included in full purchase)

      ISA Follow-up Knowledge Check

  7. 7

    Course Summary

    1. (Included in full purchase)

      Advanced Quality Assurance Auditor Training - Investigator Focused Summary

  8. 8

    Final Course Completion Tasks

    1. (Included in full purchase)

      Posttest

    2. (Included in full purchase)

      Live Webinar

    3. (Included in full purchase)

      Training Completion Survey

About the Creator

Dr. Alia Legaux is a former U.S. FDA Investigator with more than 24 years of experience monitoring, inspecting and/or auditing of FDA regulated entities, such as Clinical Research Investigator Sites, Clinical Research Organizations (“CROs”), Sponsors, Ethics Committees, Vendors (i.e. safety reporting, laboratory testing, data management, biostatistics, programming, electronic data capture, interactive voice response services, electronic clinical outcome assessments, central reading and imaging), Compounding Pharmacies, Blood Banks, and/or Tissue Banks. As an Independent Consultant, Alia provides expertise in quality assurance and compliance. She conducts domestic and international routine, directed (for-cause), qualification, re-qualification, and inspection readiness audits, as well as mock inspections of investigator sites, CROs, Sponsors, vendors, compounding pharmacies, drug manufacturers, packagers, or labelers to assess compliance with applicable regulations, protocols, investigational plans, Standards Operating Procedures (“SOPs”), International Conference on Harmonization (“ICH”) Good Clinical Practice (“GCP”), Good Manufacturing Practice (“GMP”), Good Laboratory Practice (“GLP”), Good Clinical Laboratory Practice (“GcLP”), and Good Pharmacovigilance Practice (“GVP”).

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