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Booklets

A Monitor’s Guide to Investigator Site Audits

A Practical Guide for the Good Laboratory Practice Study Director

A Practical Guide to GLP Quality Assurance

A Practical Guide to Good Laboratory Practice in the Analytical Laboratory

Auditing Computerised Systems

Booklet Bundle (eBooklets)

CAPA: Effective Approaches to Improvement

Comparison of Pharmacovigilance Regulations in Europe and Japan

Computerised System Validation

Electronic Standard Operating Procedures

Good Clinical Laboratory Practice (GCLP)

Good Clinical Practice Regulatory Authority Inspections

Guide to the Role and Responsibilities of GLP Management

Guidelines for Quality in Non-Regulated Scientific Research

Hosting an External GLP Inspection

Introduction to Quality Management

Investigators' Guide to Investigator Site Audits

Management Review

Management of the Training and Competency of Personnel in GxP and Research Environments

Pharmacovigilance Agreements (PVAs): Guidance on the Quality Oversight and Operational Aspects

Pharmacovigilance Auditing

Quality Assurance in Pharmaceutical Due Diligence

Quality Risk Management

Quality Systems Guide

Quality in Research

Remote Audits and Inspections of Pharmacovigilance Systems

The FMEA Toolkit

The Role of QA in Outsourcing

The Role of the Monitor in Veterinary Clinical Studies

Virtual Event Platform