GCP audit and inspection course
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.
Regulatory framework EU and ICH
Quality management, defining quality, risk-based approach to audit and inspection
Trial audit in practice
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
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.
A GCP audit training package has been developed on the basis of the documents developed by ICH Steering Committee Members.
PREPARATION OF THE AUDIT
Audit objectives, scope and criteria
Feasibility of the audit
Selecting the audit team
Assigning Work to the Audit Team
Preparing work documents
CONDUCT OF THE AUDIT
Generating audit findings
Preparing audit conclusions
Closing meeting(s) with auditee(s)
PREPARATION, APPROVAL AND DISTRIBUTION OF THE AUDIT REPORT.
Preparation of the audit report
Approving and distributing the audit report
Conducting audit follow-up
COMPLETING THE AUDIT