Jump to content

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

Price: USD ($) 13.00

If you are a RQA Member CLICK HERE to access the eBook for free

Get the eBook now and gain instant access:

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.

Contents

  1. Introduction to training and competency management
  2. Identifying organisational training and competency requirements
  3. Roles and responsibilities in training and competency assessment
  4. Developing training and competency programmes
  5. Training toolbox
  6. Training assessment and evaluation of training and competency programmes
    Appendix 1 Main regulatory requirements/guidelines
    Appendix 2 Trainers’ Toolbox
    Appendix 3 Example templates

Authors

The Education and Training Committee of the Research Quality Association (RQA)

ISBN

978-1-904610-36-6

Published

November 2015

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

  • BOOK10 for orders of 10 - 19 copies - 25% discount
  • BOOK20 for orders of 20 - 49 copies - 33% discount
  • BOOK50 for orders over 50 copies - 50% discount


This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.


Recommended Products

Booklets

A Monitor’s Guide to Investigator Site Audits Booklet
A Practical Guide for the Good Laboratory Practice Study Director
A Practical Guide to GLP Quality Assurance Booklet
A Practical Guide to GLP in the Analytical Laboratory Booklet
Auditing Computerised Systems Booklet
Comparison of Pharmacovigilance Regulations in Europe and Japan
Computerised System Validation Booklet
Electronic Standard Operating Procedures Booklet
Good Clinical Laboratory Practice Booklet
Good Clinical Practice Regulatory Authority Inspections Booklet
Guide to the Role and Responsibilities of GLP Management Booklet
Guidelines for Quality in Non-Regulated Scientific Research Booklet
Hosting an External GLP Inspection Booklet
Investigators Guide to Investigator Site Audits Booklet
Medical Devices Regulation Booklet
Pharmacovigilance Agreements (PVAs): Guidance on the Quality Oversight and Operational Aspects
Pharmacovigilance Auditing Booklet
Quality Assurance in Pharmaceutical Due Diligence Booklet
Quality Risk Management Booklet
Quality in Research Booklet
The Role of QA in Outsourcing Booklet
The Role of the Monitor in Veterinary Clinical Studies Booklet

Courses

C0021 Good Clinical Practice Auditing - Principles and Practice (24th Jun 2019 - 26th Jun 2019)
C0022 Good Clinical Practice Auditing - Principles and Practice (14th Oct 2019 - 16th Oct 2019)
C0041 Research Quality Assurance for Good Laboratory Practice (24th Sep 2019 - 25th Sep 2019)
C0051 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management (21st May 2019 - 22nd May 2019)
C0052 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management (3rd Sep 2019 - 4th Sep 2019)
C0053 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management (26th Nov 2019 - 27th Nov 2019)
C0061 Quality Systems for Research Laboratories (11th Jun 2019 - 12th Jun 2019)
C0081 The Auditing Course (18th Jun 2019 - 19th Jun 2019)
C0082 The Auditing Course (1st Oct 2019 - 2nd Oct 2019)
C0111 Systems Approach to Good Pharmacovigilance Practice (14th May 2019 - 16th May 2019)
C0112 Systems Approach to Good Pharmacovigilance Practice (19th Nov 2019 - 21st Nov 2019)
C0321 Process Mapping and Using Maps in Standard Operating Procedures Writing (4th Jun 2019 - 5th Jun 2019)
C0351 Practical Pharmacovigilance Auditing (11th Jun 2019 - 13th Jun 2019)
C0352 Practical Pharmacovigilance Auditing (1st Oct 2019 - 3rd Oct 2019)
C0421 Advanced Auditing Skills: Audit Analysis and Reporting (11th Sep 2019 - 12th Sep 2019)
C0441 An Introduction to Good Manufacturing Practice (10th Oct 2019)
C9011 Introduction to Computer Systems Validation (2nd Apr 2019 - 3rd Apr 2019)
C9023 Good Clinical Practice Auditing - Principles and Practice (4th Mar 2019 - 6th Mar 2019)
C9042 Research Quality Assurance for Good Laboratory Practice (2nd Apr 2019 - 3rd Apr 2019)
C9054 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management (5th Mar 2019 - 6th Mar 2019)
C9083 The Auditing Course (5th Feb 2019 - 6th Feb 2019)
C9102 Implementing Good Clinical Laboratory Practice (12th Mar 2019 - 13th Mar 2019)
C9353 Practical Pharmacovigilance Auditing (12th Mar 2019 - 14th Mar 2019)
P01 Introduction to Computer Systems Validation
P02 Good Clinical Practice Auditing - Principles and Practice
P04 Research 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 Systems Approach to Good Pharmacovigilance Practice
P32 Process Mapping and Using Maps in Standard Operating Procedures Writing
P35 Practical Pharmacovigilance Auditing
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting
P44 Introduction to Good Manufacturing Practice

Webcasts

Webcast - EU Clinical Trial Regulation
Webcast - Quality Systems
Webcast - The Biggest Change to International GCP

eLearning Products

Introduction to Good Manufacturing Practice (GMP) for Investigational Medicinal Products elearning
Introduction to Managing an Audit Programme elearning
Introduction to Risk Based Quality Systems (RBQS) elearning
Introduction to UK Clinical Trial Regulations elearning

Share