Última atualização: Agosto 17, 2026
What is GCP Auditor certification?
GCP Auditor training and certification.
Here is a list of covered topics:
GCP AUDITING GUIDELINE
Audits and Inspections in Clinical Research
Investigational Product Development, the FDA, and Good Clinical Practice Guidelines
Auditing as a Profession and Compliance Tool
The Types of Clinical Research Audits and Preparation
Quality Systems for Auditing
Risk-Based Auditing and Developing Risk-Based Auditing Plans
The Auditing Process: Clinical Investigator
The Auditing Process: Institutional Review Board/Ethics Committee
The Auditing Process: Sponsor/CRO
Gathering and Disseminating Information: Verbal and Written Communication
Regulatory Classification and Communication: Recent Inspection Findings
FDA Inspections of Clinical Investigators
How to prepare for an inspection for Good Clinical Practice by the Medicines and Healthcare products Regulatory Agency (MHRA)
Optional information:
Guidance for the preparation of GCP inspections
Recommendation on inspection procedures for the verification of good clinical practice compliance
Guidance for the conduct of GCP inspections
Annex I to Guidance for the conduct of GCP inspections – investigator
Annex II to Guidance for the conduct of GCP inspection – clinical laboratories
Annex III to Guidance for the conduct of GCP inspections – computer systems
Annex IV to Guidance for the conduct of GCP inspections – Sponsor and CRO
Annex V to Guidance for the conduct of GCP inspections – Phase I Units
Annex VI to Guidance for the conduct of GCP inspections – Record keeping and archiving of documents
Annex VII to Guidance for the conduct of GCP inspections – Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials
Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures
Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC
Guidance for the communication on GCP inspections and findings
Procedure for standardisation of GCP inspection entries in EudraCT
Guidance for the preparation of Good Clinical Practice inspection reports
Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice
e-mail: [email protected]
Revisão de Caso Científico
Você gostaria de entender se os programas clínicos atuais, desenvolvimentos de pesquisa recentes, ou abordagens emergentes podem ser relevante para sua situação individual?
Compartilhe sua dúvida com nossa equipe de pesquisa científica e receba informações focadas nas áreas de pesquisa atual que podem ser relevante para o seu caso.
- Revisão das informações que você fornece
- Informações relevantes sobre pesquisas e programas clínicos
- Uma resposta clara focada na sua situação
Sem obrigação. Sua pergunta será analisada confidencialmente.
Apenas informações educacionais e de pesquisa. Este serviço não constituem aconselhamento médico, diagnóstico, prescrição, ou um personalizado recomendação de tratamento.
