GCP audit and inspection course

Overview :

This GCP auditing course  is designed to provide practical training resulting in a harmonised, common audit methodology in Europe. The ICH GCP guideline implemented in the EU, Japan and the USA is being widely incorporated into guidelines worldwide. Systems audits, previously seen as “advanced auditing”, have become a basic task of many audit groups and are an essential element of inspections in Europe.

The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.


Key Topics

Regulatory framework EU and ICH

Quality management, defining quality, risk-based approach to audit and inspection

Trial audit in practice

System audits

Communication of audit findings

Inspections by European and other authorities


GCP audit and inspection training materials:

A must-have guide for any professional in the drug manufacturing industry

The Good Clinical Practice (GCP) audit  is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code.

Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.

This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits.

The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals.

Among the topics discussed:

Good Clinical Practices  and therapeutic product development in clinical research

The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee

The roles and responsibilities of the clinical trial investigator

The inspection preparation

The Audit Report and the Form 483

Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

Learning Objectives

Upon completion, attendees will be able to:

Identify and define the principles and requirements for GCPs

Define the basic roles and responsibilities of the sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials

Understand the GCP audit  process for sponsors

Know when to conduct audits of vendors, sites, IRBs and laboratories

Ensure that your data and supporting documentation are accurate and presentable for inspection

Gain knowledge concerning common outcomes and findings in clinical trials

Understand how to respond to an audit to avoid further regulatory consequences

Learn how to detect and prevent fraud and misconduct in clinical trials

Fully understand the consequences which result when proper procedures are not followed, through the use of examples

Case study analysis, exercises and videos will be used throughout the course to provide insight and promote discussion.

gcp certificate

gcp certificate

A GCP audit  training package  has been developed on the basis of the documents developed by ICH Steering Committee Members.



Audit assignments

Audit objectives, scope and criteria

Feasibility of the audit


Selecting the audit team

Document Review

Assigning Work to the Audit Team

Preparing work documents


Opening meeting

Collecting information

Generating audit findings
Preparing audit conclusions

Closing meeting(s) with auditee(s)


Preparation of the audit report

Approving and distributing the audit report

Conducting audit follow-up




FAQ regarding GCP audit course:

– Duration of course
Duration of GCP audit course Activities – Self-determined ( we recommend minimum 1 week, maximum 8 weeks)
All course materials available 24 hours after purchase
Self-paced:   Self-paced GCP audit courses have no scheduled start date.  You may access the course material 24 hours after purchase for 60 days and you define the pace at which you would like to review the material. In addition, a discussion board may be available 24/7 to discuss class topics and exercises with other students and the subject matter expert.
Online Course Materials Access:  This is when you will have access to the online GCP audit course materials.  These materials may include access to the course book, discussion board and all other online tools and templates provided to the class. Course materials are delivered in a predetermined pace for facilitated courses.  Self-paced Blended Learning classes provide full access to all course materials 24 hours after purchase for 60 days.
– Is the course conducted by prescheduled online webinar or the course content is available for download upon registration?
GCP audit course content is available for download upon registration
– Whether your provide the GCP Auditor Certification and by which international organizations it is recognized?
Yes. GCP Auditor certificate issued by NBScience ( United Kingdom)
GCP audit and inspection course
GCP audit and inspection course
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