gcp sertifikat

On-line corso di formazione in materia di revisione ed ispezione GCP

recognized by International Society of GxP Standards

Panoramica :

Questo corso di auditing GCP è progettato per fornire una formazione pratica con un conseguente armonizzata, metodologia di audit comune in Europa. La linea guida ICH GCP implementato nella UE, Giappone e Stati Uniti è ampiamente incorporati in linee guida di tutto il mondo. audit dei sistemi, visto in precedenza come “auditing avanzato”, sono diventati un compito fondamentale di molti gruppi di audit e sono un elemento essenziale delle ispezioni in Europa.

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

gestione della qualità, 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

obiettivi formativi

Al completamento, 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 Audit GCP 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 by ICH membri del comitato direttivo.

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, Svezia

 

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

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

 

Sig. Shinobu Uzu
ministero della Salute, Labour & Welfare Tokyo, Giappone

 

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

 

Sig. Kazutaka Ichikawa
Japan Pharmaceutical Manufacturers
AssociationJPMA Tokyo, Japan Mr. Kohei Wada
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd. Tokyo, Giappone

 

Dr. Justina A. Molzon
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration Rockville, MD, Stati Uniti d'America

 

Dr. Robert A. Yetter
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration Rockville, MD, Stati Uniti d'America

 

Dr. Alice Till
Science Policy and Technical Affairs
Pharmaceutical Research and Manufacturers of AmericaPhRMA
Washington DC, Stati Uniti d'America

 

Dr. Peter K. Honig
Worldwide Regulatory Affairs and Product Safety
Merck Research Laboratories North Wales, PA, Stati Uniti d'America

 

Mme Alicia D. Greenidge
International Federation of Pharmaceutical
Manufacturers AssociationsIFPMA Geneva, Svizzera

 

Dr. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Manufacturers AssociationsIFPMA Geneva, Svizzera

 

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

Dr. Lembit Rago
Quality Assurance and Safety : medicinali
HTP/EDM/QSM
World Health Organization Geneva, Svizzera

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

Domande:
Duration of course
Duration of GCP audit course ActivitiesSelf-determined ( we recommend minimum 1 settimana, massimo 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 giorni.
– È il corso condotto da webinar on-line prescheduled o il contenuto del corso è disponibile per il download al momento della registrazione?
GCP audit course il contenuto è disponibile per il download al momento della registrazione
– Sia che il vostro fornire la certificazione GCP effettivo e con cui le organizzazioni internazionali si riconosce?
sì. certificato GCP Sindaco rilasciato da NBScience ( Regno Unito), recognized by International Society of GxP Standards (Francia )

 

gcp certificate

gcp certificate

 

terapia con cellule staminali