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Booklets

* All eBook only publications are indicated with an asterisk.

 

Booklet Bundle

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A Monitor’s Guide to Investigator Site Audits

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A Practical Guide for the Good Laboratory Practice Study Director

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A Practical Guide to GLP Quality Assurance

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A Practical Guide to Good Laboratory Practice in the Analytical Laboratory

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Auditing Computerised Systems

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CAPA: Effective Approaches to Improvement*

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Comparison of Pharmacovigilance Regulations in Europe and Japan*

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Computerised System Validation

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Electronic Standard Operating Procedures

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Good Clinical Laboratory Practice (GCLP)

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Good Clinical Practice Regulatory Authority Inspections

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Guide to the Role and Responsibilities of GLP Management

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Guidelines for Quality in Non-Regulated Scientific Research*

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Hosting an External GLP Inspection

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Investigators' Guide to Investigator Site Audits

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

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Medical Devices Regulation Booklet

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

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Pharmacovigilance Auditing

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Quality Assurance in Pharmaceutical Due Diligence

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Quality Risk Management

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Quality Systems Guide

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Quality in Research

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The FMEA Toolkit*

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The Role of QA in Outsourcing

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The Role of the Monitor in Veterinary Clinical Studies

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