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

 

Details –  https://nbscience.com/clinical-research-services/on-line-training-course-on-gcp-audit-and-inspection/

 

gcp certificate

gcp certificate

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