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This introductory booklet contains the core ideas underpinning the development and management of effective training, development and competency systems and programmes, however small or large. It discusses the drivers behind and principles of training, development and competency management. It also touches upon the various training methodologies and contains some useful tips for trainers.
This guidance has been developed with best practice in mind and it is intended that the reader considers the context of how this guide fits within their own individual organisational structure and needs. Those new to the concepts can use the ideas to shape their own understanding of the principles of training and competency management.
This guide aims to provide a solid overview of a wide topic in just a few pages. It comprises outlines of the principles and best practice, supported by tools such as example forms and templates that can be adapted for use within your own organisation. A glossary of terms used throughout the booklet has been included to aid common understanding of the terminology. Additionally, the booklet contains useful resources for further reading.
The Education and Training Committee of the Research Quality Association (RQA)
978-1-904610-36-6
November 2015
A Monitor’s Guide to Investigator Site Audits
A Practical Guide for the Good Laboratory Practice Study Director
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory
Auditing Computerised Systems
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
Investigators' Guide to Investigator Site Audits
Pharmacovigilance Agreements (PVAs): Guidance on the Quality Oversight and Operational Aspects
Pharmacovigilance Auditing
Quality Assurance in Pharmaceutical Due Diligence
Quality Risk Management
Quality in Research
The Role of QA in Outsourcing
The Role of the Monitor in Veterinary Clinical Studies
P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Quality Assurance for Good Laboratory Practice
P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
P06 Quality Systems for Research Laboratories
P08 The Auditing Course
P10 Implementing Good Clinical Laboratory Practice
P11 A Systems Approach to Good Pharmacovigilance Practice
P14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment
P32 Process Mapping and SOP Writing
P35 Practical Pharmacovigilance Auditing
P36 Practical Approach to Good Pharmacovigilance Regulatory Inspections
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP02 Good Clinical Practice Auditing - Principles and Practice REMOTE LEARNING
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management REMOTE LEARNING
RP06 Quality Systems for Research Laboratories REMOTE LEARNING
RP14 Good Clinical Practice Inspection Preparation - Navigating a Rapidly Changing Environment REMOTE LEARNING
RP16 Good Laboratory Practice Refresher and Hot Topics REMOTE LEARNING
RP22 Risk Management in Clinical Trials REMOTE LEARNING
RP32 Process Mapping and SOP Writing REMOTE LEARNING
RP35 Practical Pharmacovigilance Auditing REMOTE LEARNING
RP44 Introduction to Good Manufacturing Practice REMOTE LEARNING
Webcast - EU Clinical Trial Regulation
Webcast - Quality Systems
Webcast - The Biggest Change to International GCP
Introduction to Good Manufacturing Practice (GMP) for Investigational Medicinal Products elearning
Introduction to Risk Based Quality Systems (RBQS) elearning