概要 :

この GCP監査コース is designed to provide practical training resulting in a harmonised, ヨーロッパでは一般的な監査方法論. The ICH GCP guideline implemented in the EU, 日本とアメリカでは広く世界中のガイドラインに組み込まれています. システム監査, previously seen as “advanced auditing”, 多くの監査グループの基本的なタスクとなり、ヨーロッパでの検査の重要な要素できました.

教材は、定期的に相互承認と受け入れのための道を開くために、経験の共有と共通専門的なアプローチの目的で更新されます, コスト削減と効率化を刺激します, 患者と医療の恩恵に速い医薬品の開発が可能に.


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

ザ・ グッド臨床実習 (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運営委員会のメンバー.



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







- コース期間
Duration of GCP audit course 活動 - 自己決定 ( we recommend minimum 1 week, maximum 8 週間)
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. 加えて, 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 日々.
- 予めスケジュールオンラインウェビナーやコース内容によって実施コースは、登録時にダウンロード可能です?
GCP audit course content is available for download upon registration
- あなたは、GCPの監査証明を提供するかどうか、国際機関は、それが認識されることにより、?
はい. GCP Auditor certificate issued by NBScience ( イギリス)
カテゴリー: course