OVERVIEW

Good Clinical Practice (GCP) Auditing Course is organized by NBScience limited.

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.

Abstract: The Scientific Program Committee invites you to submit your research in the form of a one-page abstract (2500 characters) . We welcome scholarly research-based submissions . Case study abstracts will also be welcomed. Abstracts should include unpublished material and data. Material that has been formally published by the abstract submission dates will not be accepted. Most abstracts without data to support findings will be rejected. However, abstracts that describe study design and methods for well-developed and/or funded studies (i.e., no abstracts for pilot or preliminary studies) may be considered for poster presentation depending on abstract quality. All abstracts will be anonymously peer reviewed, scored and chosen on merit for poster presentation. Individuals whose abstract are selected will be required to register