On-line training course on GCP audit and inspection

Panoramica :

This GCP auditing course is designed to provide practical training resulting in a harmonised, metodologia di audit comune in Europa. La linea guida ICH GCP implementata nell'UE, Il Giappone e gli Stati Uniti vengono ampiamente incorporati nelle linee guida in tutto il mondo. Audit di sistema, previously seen asadvanced auditing”, sono diventati un compito fondamentale di molti gruppi di audit e sono un elemento essenziale delle ispezioni in Europa.

Il materiale del corso viene aggiornato regolarmente con l'obiettivo della condivisione delle esperienze e di un approccio professionale comune al fine di aprire la strada al riconoscimento e all'accettazione reciproci, ridurre i costi e stimolare l'efficienza, allowing faster medicinal product development to the benefit of the patients and health care.

gcp certificate

gcp certificate

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

Il Buona pratica clinica (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

UN GCP audit training package has been developed on the basis of the documents developed byICH Steering Committee Members.

We wish to thank to:

Dr. Peter Arlett
Head of Sector for Pharmacovigilance and Risk Management
European Medicines Agency London UK

Dr. Tomas Salmonson
Medical Products Agency
Preclinical and Clinical Investigation Unit Uppsala, Sweden

Dr. Christine-Lise Julou
European Federation of Pharmaceutical
Industries AssociationsEFPIA Brussels, Belgium

Dr. Andrй W. Broekmans
Schering Plough Research Institute The Netherlands

Mr. Shinobu Uzu
Ministry of Health, Labour & Welfare Tokyo, Japan

Dr. Satoshi Toyoshima
Pharmaceuticals and Medical
Devices Agency (PMDA) Tokyo, Japan

Mr. Kazutaka Ichikawa
Japan Pharmaceutical Manufacturers
Associazione – JPMA Tokyo, Giappone Signor. Kohei Wada
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd. Tokyo, Japan

Dr. Giustina A. Molzon
Centro per la valutazione e la ricerca sui farmaci (CDER)
Food and Drug Administration Rockville, MD, Stati Uniti d'America

Dr. Roberto A. Yetter
Centro per la valutazione e la ricerca biologica (CBER)
Food and Drug Administration Rockville, MD, Stati Uniti d'America

Dr. Alice Till
Science Policy and Technical Affairs
Ricerca farmaceutica e produttori americani – PhRMA
Washington DC, Stati Uniti d'America

Dr. Pietro K. Honig
Worldwide Regulatory Affairs and Product Safety
Laboratori di ricerca Merck Galles settentrionale, PAPÀ, Stati Uniti d'America

Sig.ra Alicia D. Greenidge
International Federation of Pharmaceutical
Associazioni di produttori – IFPMA Ginevra, Switzerland

Dr. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Associazioni di produttori – IFPMA Ginevra, Switzerland

Mr. Mike Ward
International Policy Division
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Products and Food Branch Health Canada

Dr. Lembit Rago
Garanzia di qualità e sicurezza : Medicines
World Health Organization Geneva, Switzerland

Dr. Petra Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne, Switzerland

Duration of course
Duration of GCP audit course ActivitiesSelf-determined ( we recommend minimum 1 week, maximum 8 settimane)
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. Inoltre, 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 ( Regno Unito)

gcp certificate

gcp certificate

GCP training online
Service Type
GCP training online
Provider Name
Londra,Regno Unito-
GCP training online

1 Comment

NBScienza · March 13, 2020 at 9:40 pm

Advanced GCP Auditor training and certification

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