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

5 Chapters · 6 Lessons

  1. 1

    Introduction to Quality Assurance in Clinical Trials

    1. (Included in full purchase)

      Roles and Responsibilities of an Auditor

  2. 2

    Planning and Preparing for CSV Audits

    1. (Included in full purchase)

      Preparation Strategies

  3. 3

    Conducting Effective CSV Audits

    1. (Included in full purchase)

      Engaging with Site Staff

  4. 4

    Audit Reporting and Follow-Up

    1. (Included in full purchase)

      Follow-Up Actions Post-Audit

    2. (Included in full purchase)

      Adequate Corrective and Preventive Action (CAPA) Plans

  5. 5

    Improving Quality Assurance Practices

    1. (Included in full purchase)

      Staying Current with Regulations

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”). Alia shares her knowledge in the varied training courses offered by CRSC.

Ready to Transform Your Career?

Enroll in our Advanced Quality Assurance Auditor Training - CSV Focused today and unlock a world of opportunities in the field of clinical trial auditing.

$1,999.00

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