Terms and Conditions and FAQs

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The RQA is committed to the conduct of the highest quality clinical research. As part of that commitment, and for compliance with Good Clinical Practice (GCP) requirements, RQA has developed this guide to help monitors prepare and understand the activities and rationale for auditing investigator sites.

Contents

1. How are Investigator Sites Selected for Audit?
2. When are Sites Audited?
3. Why are Audits Performed?
4. What is the Audit Procedure?
5. Reporting and Follow up
6. Investigator Letters
7. Audit Certificates
8. Why are Audits Performed?
9. Further Information
10. References
11. Appendix

Authors

RQA GCP Committee

ISBN

978-1-904610-18-2

Published

December 2008
Reprinted January 2013

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Good Laboratory Practice (GLP) regulations require the appointment of a Study Director by Test Facility Management for each study.

By virtue of the legal status of the Study Director in testifying to the performance, compliance, accuracy and integrity of the conduct of the study, its data and the final report, the role of the GLP Study Director is critical to study integrity and regulatory compliance and potentially the most complex.
This guidance is intended to be read in conjunction with the Organisation for Economic Co-operation and Development (OECD) Series on Principles of GLP and Compliance Monitoring Number 8 (Revised) Consensus Document, “The role and responsibilities of the Study Director in GLP studies". 

The booklet addresses both the Regulatory role of the Study Director, whilst also addressing matters potentially affecting Study Director’s that are not defined by GLP regulation or guidance, but may be imposed by the role and position of the Study Director within a commercial organisation.

1. Introduction
2. OECD GLP definition of a Study Director
3. The single point of control
4. Appointment of the Study Director
5. Qualifications and training of the Study Director
6. Availability
7. Replacement of the Study Director
8. Responsibilities of the Study Director as defined by OECD GLPs
9. Study planning
10. Multi-site studies
11. Study oversight
12. Quality control
13. Reporting of the study
14. Archiving
15. Managing relationships with others

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UK GLP Regulations and OECD GLP Principles define the requirements of a testing facility with respect to the performance of GLP studies but give little/no practical guidance for personnel working in the analytical laboratory. This document aims to provide useful guidance for laboratory personnel, but should not be relied upon absolutely since it is not possible to consider and address the entire variety of analyses performed in a laboratory environment.

This publication provides guidance to Management on the application of GLP Principles in all laboratories undertaking analytical procedures.  Further guidance for Management can be found in the RQA publication: A Guide to the Roles and Responsibilities of GLP Management.  It also aims to provide guidance to laboratory staff in the organisation and conduct of their work in order to ensure compliance with GLP principles.

Contents

1. Introduction
2. Management
3. Laboratory Personnel
4. Study Director and/or Principal Investigator
5. Quality Assurance
6. Facilities
7. Equipment
8. Standard Operating Procedures (SOPs)
9. Study Plan
10. Laboratory Procedures
11. Investigation of Unexpected or Atypical Results
12. Data Integrity
13. Reporting of Results
14. Archives

ISBN

1-904610-35-9

Published

August 2016

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UK GLP Regulations and OECD GLP Principles define the requirements of a testing facility with respect to the performance of GLP studies but give little/no practical guidance for personnel working in the analytical laboratory. This document aims to provide useful guidance for laboratory personnel, but should not be relied upon absolutely since it is not possible to consider and address the entire variety of analyses performed in a laboratory environment.
This publication provides guidance to Management on the application of GLP Principles in all laboratories undertaking analytical procedures.  Further guidance for Management can be found in the RQA publication: A Guide to the Roles and Responsibilities of GLP Management.  It also aims to provide guidance to laboratory staff in the organisation and conduct of their work in order to ensure compliance with GLP principles.

Contents

• Introduction
• Management
• Laboratory Personnel
• Study Director and/or Principal Investigator
• Quality Assurance
• Facilities
• Equipment
• Standard Operating Procedures (SOPs)
• Study Plan
• Laboratory Procedures
• Investigation of Unexpected or Atypical Results
• Data Integrity
• Reporting of Results
• Archives

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This booklet has been produced by the RQA Computing Committee to provide guidance on current best practice in the auditing of computerised systems. The principles are applicable to all computerised systems audits, but particularly those used within the pharmaceutical industry.

Contents

1. Foreword
2. Acknowledgement
3. Introduction
4. Objective
5. The System Life Cycle (SLC)
6. Risk Management
7. Validation Deliverables
8. Change Control 
9. Planning an Audit 
10. Audit Types 
11. The Principles of Data Integrity 
12. Archiving Principles 
13. Regulations and Guidance 
14. References 
15. Appendix I – Computerised System Audit Checklists 
16. Appendix II – Definitions and Acronyms

Authors

Christopher Montgomery and the RQA Computing Committee

ISBN

978-1-904610-22-9

Published

January 2013

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No clinical research is free of quality issues; in many cases quality issues are unavoidable. It is vitally important to address all quality issues promptly and properly.
Corrective action and preventive action (CAPA) is the process which investigates and solves identified issues by identifying the causes and taking corrective actions, which prevents a recurrence of the root causes and avoids any potential noncompliance.
CAPA should be an integral part of the Issues Management segment of a risk-based Clinical Quality Management System. According to ICH Q10, CAPA methodology should result in product and process improvements, and enhanced product and process understanding.

Contents 

1. Definitions 
2. Effective CAPA 
3. When does CAPA start? 
4. Define the issue and scope 
5. Take immediate action 
6. Perform root cause analysis 
    6.1 The 5-Why approach 
    6.2 Fishbone diagram 
    6.3 Listening during root cause analysis 
7. Plan the corrective action(s) 
8. Implement the corrective action(s) 
9. Verify that the plan works 
10. Preventive action 
11. Don’t forget! 

Author

Ludmila Kutakova

Published

May 2018

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It has been getting more important for MAHs to comprehend PV regulations and regulatory expectations in Europe and Japan since PV activities should be a global system in itself. Considering the importance of stakeholders in the European Union and Japan in producing hiqh quality medicinal products around the world and their determining role in directing drug safety regulations, it is important to compare these regulations and expectations and to clarify the different aspects of PV activities and their characteristics. Therefore, the Research Quality Association (RQA) and the Japanese Society of Quality Assurance (JSQA) initiated a joint effort in which the regulations from both continents are compared in order to bring the similarities and differences in each of the important topics for PV. This booklet reflects the similarities and differences in the form of short versions for each of the subjects, furthermore a summary table is also incorporated at the end of it on order to have a quick view of all these comparisons and the related document which has served as reference. 

Contents

1. Additional monitoring

2. Aggregate reporting

3. Evaluation of Safety Data

4. ICSR Reporting

5. Inspections

6. Literature Search

7. Pharmacovigilance System Master File

8. Post Marketing Studies

9. QPPV

10. Quality Management System

11. Reference Safety Information

12. Risk Management Plan (RMP)

13. Safety Communication

14. Signal detection

Authors

RQA 
Project Leader - Ana-Maria Aguirre-Arteta, F. Hoffmann-La Roche Ltd
plus PV Committee members

JSQA 
Project Leader - Genshu Nakamura, Biogen Japan Ltd
plus JSQA members 

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This booklet has been produced by the RQA Computing Committee to provide guidance on current best practice and the application of risk management in Computerised System Validation. The Principles are applicable to all regulated computerised systems, particularly those used within the pharmaceutical industry.

Much of the information within this booklet has been developed concurrently with the RQA Professional Development Course on 'Auditing Computerised Systems' and 'Computerised System Validation'.

Contents

1. Introduction
2. The Validation Process
3. The Regulations
4. Risk Management
5. Project Deliverables
6. Validation Process
7. Qualifications
8. Validation Strategy
9. Appendix A - Example User Requirements Specification
10. Appendix B - Example Functional Design Specification
11. Appendix C - Example System Design Specification
12. Appendix D - Example Traceability Matrix
13. Appendix E - Example Test Script
14. Appendix F - References
15. Appendix G - Example Architecture Diagram
16. Appendix H - The Iterative or Prototyping CSV Model

Authors

Chris Montgomery and the RQA Computing Committee

ISBN

978-1-904610-20-5

Published

First printed December 2008

Reviewed January 2013

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RQA published a Guideline on the Management of Electronic Standard Operating Procedures in December 1998. Since then companies working in the GxP industries have gained experience of electronic SOPs through the design and implementation of their own systems. In September 2001, interested parties from a variety of user organisations formed a Working Party under the auspices of RQA to co-operate and produce an update to the 1998 guideline in the form of an RQA booklet.

In 2013 the RQA  Computing Committee reviewed and re-issued the booklet due to ongoing demand for the booklet, reflecting the evolution of eSOP systems since 2000.

Contents

1. Introduction
2. Definitions
3. System Components and Functions
4. eSOP System Types
5. Benefits of eSOP System
6. Requirements for eSOP System
7. Choosing and Implementing a System
8. Auditing the System
9. Bibliography and Further Reading
10. Acknowledgements

Authors

Barbara Kay-Farrow, Matthew Davies, Tony Harrington, Chris Montgomery and Sarah Pickersgill

ISBN

978-1-904610-30-4

Printed

January 2014

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An International Quality System for Laboratories which undertake the analysis of samples from clinical trials.

This guideline was originally produced in 2002 with the purpose of providing guidance on the quality system required in laboratories that undertake the analysis of samples from clinical trials. Since that time, this guidance has been widely adopted internationally by many organisations such as the World Health Organisation (WHO), pharmaceutical companies, research institutions, non-governmental organisations (NGOs), hospitals, contract research organisations (CROs) and academia.

This document is primarily an update of the original GCLP guideline. Many of the changes made are cosmetic, but others are influenced by the authors' experiences gained in the application of GCLP in many different laboratory settings and trials around the world. In addition, an increasing number of regulatory audits have included those laboratories involved in the support of clinical trials and, as a result of these audits, the general expectations for laboratories have to some degree been clarified. These expectations have also been reflected within this revision of the GCLP Guideline. In all cases it is believed that the changes made only clarify the earlier guidance whilst enhancing patient safety and data integrity.

Contents

1. Preface
2. Scope
3. Introduction
4. Definitions
5. Organisation and Personnel
6. Facilities
7. Equipment, materials and reagents
8. Standard Operating Procedures (SOPs)
9. Planning of the Work
10. Sub-Contracting
11. Trial Materials
12. Conduct of the Work
13. Reporting Results
14. Quality Control
15. Quality Audit
16. Retention and Archiving of Records
17. Confidentiality
18. Blinding
19. Patient Safety

Authors

Tim Stiles and Vanessa Grant

ISBN

978-1-904610-21-2

Published

January 2012, reprinted December 2012

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With the implementation of the EU Clinical Trial Directive in 2004, there has been a significant increase in the number of Regulatory Authority GCP inspections in the EU.

With twenty-seven national authorities within the EU and other authorities such as the US FDA actively inspecting, it has become a very busy time for those involved in clinical development.

This guidance book aims to provide helpful advice and tips on the process of Sponsor and Investigator Site GCP inspections by Regulatory Authorities.

The process of the inspection may vary between inspectorates, but the principle remains the same. Everyone wants to succeed and "do well" in inspections, and this guide will help us to achieve this.

Contents

1. Background
2. Sponsor Inspections
3. Investigator Site Inspections
   

Authors

Bruce Seymour-Taylor and members of the RQA Good Clinical Practice Committee

ISBN

978-1-904610-17-5

Published

December 2012

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This guidance booklet has been produced by a group of members from the RQA Good Laboratory Practice (GLP) Committee. The group was chaired by John McRoberts (sanofi-aventis), and included Mark Goodwin (GlaxoSmithKline), Jane Shackleton (York Bioanalytical Solutions) and Sue Gledhill (formerly AstraZeneca).

The RQA GLP Committee identified a gap in available guidance around the role and responsibilities of test facility management. It was considered that management, whether new to the role or well established, would welcome further interpretation of their GLP responsibilities. The group set its objective to produce a booklet that provided additional explanation and practical options for management to meet their GLP obligations.

Contents

1. Introduction
2. Who is Management
3. Integrating GLP into the Business
4. Maintaining a GLP Compliant Facility
5. Responsibilities Test Facility Management
6. Corrective Action and Preventive Action
7. Role of Management During Regulatory Inspections
8. Use of Non-GLP Facilities
9. Notification of Changes at a Test Facility
10. Legal Matters

Authors

RQA GLP Committee

ISBN

978-1-904610-19-9

Published

First Published October 2009, this edition reviewed January 2013

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The aim of this guideline document is to facilitate the straight forward development of a Quality System in any research institution, irrespective of discipline, which has no previous experience of such process. A structure of ten subject matter sections has been adopted so as to provide a simple, pragmatic "get started" model for Quality systems in Non-Regulated Scientific Research. Evaluation of risk should drive the order of their implementation.

Contents

1. Project Management
2. Personnel
3. Facilities
4. Equipment
5. Materials and Reagents
6. Procedures
7. Research and Work Records
8. Computer Systems
9. Research Review
10. Quality System

Authors

RQA Working Party on Quality in Non-Regulated Research 

Price

Electronic version only (PDF) £5.00

VAT on Electronic Books is chargeable in the UK and EU. Please see the 'How to Purchase' page for further details.

Published

June 2008

Price: USD ($) 218.72

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Although the manner in which Regulatory Authorities undertake inspections is covered in various publications there are few analogous publications on how to host an inspection. A need was identified during the preparation of another booklet 'A Practical Guide to GLP Quality Assurance' by the RQA GLP Committee. It was decided that this need would be addressed by a further RQA publication.

Contents

1. Introduction
2. Preparation Prior to an Inspection
3. Programme of Visit
4. Post Inspection
5. Benefits of External GLP Inspections
6. Conclusion
7. Definitions/Glossary
8. Abbreviations

Authors

RQA GLP Committee

ISBN

978-1-904610-27-4

Published

March 2013

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The RQA is committed to the conduct of the highest quality clinical research. As part of that commitment, and for compliance with Good Clinical Practice (GCP) requirements, RQA has developed this guide to help investigators prepare and understand the activities and rationale for auditing investigator sites.

Contents

1. Why are Audits Performed?
2. How are Investigator Sites Selected for Audit?
3. What is Good Clinical Practice?
4. What will the Audit Involve?
5. Investigator Site Audit Flowchart
6. Regulatory Inspections
7. Further Information

Authors

RQA GCP Committee 

ISBN

978-1-904610-23-6

Published

February 2013

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Quality is defined by ‘ISO 9000:2015 Quality management systems – Fundamentals and vocabulary’ as the degree to which a set of inherent characteristics fulfils requirement. To meet the definition prescribed by ISO, it is necessary to pre-determine the fundamental characteristics, standardise the approach and execution of work, as well as establishing tools and criteria to measure the degree of fulfilment. In short, it is almost impossible to run a successful and high-quality company without a Quality Management System (QMS) of some kind.

Contents

• Chapter 1: Role of Top Management in Quality Management System and Introduction to Management Review
• Chapter 2: Plan
• Chapter 3: Do
• Chapter 4: Check
• Chapter 5: Act
• Summary
• Attachment 1: Example Agenda Template
• Attachment 2: Example Minutes Template
• References

Author

Natalia Janik - Natalia has clinical research experience across a wide range of sectors, from cosmetics to First-in-Man trials. She has an excellent understanding of risk and is an advocate of the risk-based-approach. Natalia’s current role is QA Associate at Illingworth Research Group Ltd. She has been a member of the RQA since 2014, and this is her first project as part of the RQA Volunteer Programme.

Published 

February 2018

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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.

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

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An increasing number of RQA members have in recent years worked with, or been asked to assist in medical device related projects. The medical device arena is complex; medical devices range from basic tongue depressors to brain stents and pacemakers, with drug/device combination products also included in the family. Information relating to the quality and regulatory aspects of medical devices is not easily accessible, especially if you don't know where to look. RQA identified a need to provide members with a consolidated summary of information on medical devices in one easy booklet.

Contents

1. The Directives
2. Classification
3. Pathways To The CE Marking Conformity Assessment Routes
4. The Role of the Notified Body
5. Essential Requirements
6. Quality Risk Management
7. Clinical Evaluation
8. Technical Documentation
9. Quality Management Systems
10. Post-market surveillance
11. Combination Products
12. Other Regulatory Requirements

Authors

Zelda Carr, Neil Buckley, David Franks, Louise Olliver, Carolyn Mann, Belinda Pierce, Andrew Tipping, Fraser Smith, Merel de Jonge, Alan Dench, Yvanne Enever, Henny Koch, Kevin Butcher, Hannah Jenkins & Julian Reeves.

ISBN

978-1-904610-13-7

Published

First published October 2009, republished July 2013

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The purpose of this booklet is to provide some guidance on the quality oversight and operational aspects of PVAs for professionals working in PV, Legal, Regulatory Affairs and QA departments.

The booklet aims to provide you with:

•  An overview of the types of agreement
•  The items which you may need to consider when developing  and implementing PVAs 
•  The items to consider and to prioritise for QA oversight 
•  A matrix of the typical clauses according to your agreement type.

Contents

Background/Purpose

Types of agreements  

• Co-development arrangements 
• Co-Marketing and Licensing  
• Distribution and Wholesaler Agreements 
• Manufacturing arrangements 
• Purchase agreements/tenders/charitable donations 
• Service level agreements  
• Business service providers for marketing related activities   
• Service providers for delegated PV activities or PV supporting functions   
• Collaboration arrangement with not-for-profit organisation
• Operational aspects 

Quality oversight

• PVA Compliance 
• Point to consider when developing a quality oversight strategy  
• Methods of quality oversight 
• Questionaire assessment 
• Conclusions 

Authors

RQA 
Sandra Dunlavy, Astellas 
Magda Daudin, Janssen 
Andrew Cooper, GlaxoSmithKline 
Kieran O’Donnell, TMC Pharma Thomas Henn, United Therapeutics Europe Ltd 

JSQA 
Tomoko Yanai, Santen Pharmaceutical Co., Ltd 
Shigeo Suzuki, MSD K.K. Ayami Komatsu, Japan Tobacco INC. 
Teiki Iwaoka, CAC Croit Corporation 
Madoka Sasaki, Sumitomo Dainippon Pharma Co. Ltd. 

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The purpose of this booklet is to provide guidance to auditors to enable them to conduct effective audits of the PV system.  In 2012, PV audit became a legal requirement in the EU, according to Directive 2010/84/EU.  The intention of this publication is to capture the primary areas for review, to assist industry personnel with implementation of this regulatory requirement.  However, this booklet may not be all inclusive and there may be additional processes or functional groups that could be included within the scope of an audit.  The booklet is considered to be fairly comprehensive, capturing activities managed by central functions and those that may be managed by an affiliate company.  It is envisaged that an auditor may select areas from this booklet of relevance to the system that they wish to audit.

While the focus of this booklet is the EU legislative requirements, the reality with regards to PV is that multinational companies operate in a global environment.  Therefore, while national regulation must of course be considered both within the EU and ex-EU, it is anticipated that this guide may be applied as a basis for PV audit across geographical boundaries.

For those new to PV auditing, the content of this publication may appear a little overwhelming at first.  We hope that it will provide some guidance as to where to start, what to include and where key areas of focus could be.

Contents

1. Introduction
2. Background
3. Types of audits to consider
4. Scope of a pharmacovigilance (PV) audit
5. Planning and conduct of audits
6. Topics for review
   6.1  Qualified person for pharmacovigilance (QPPV)
   6.2  Medical information/call centres
   6.3  Case processing
   6.4  Literature review
   6.5  Reference safety information (RSI)
   6.6  Aggregate/periodic reports
   6.7  Product Quality Complaints (PQCs) associated with AE
   6.8  Signal detection/signal management
   6.9  Risk management/minimisation and pharmacovigilance planning
   6.10 Interventional clinical studies
   6.11 Commercial activities
   6.12 ICSR regulatory reporting (paper/E2B)
   6.13 Quality management system (QMS) audits
   6.14 Pharmacovigilance computer systems
   6.15 Auditing safety data exchange agreements
   6.16 External service providers (CROs/vendors)

Authors

Pam Bones and members of the RQA Good Pharmacovigilance Practice Working Party

ISBN

978-1-904610-33-5

Reprinted

February 2017

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This booklet has been produced by RQA and SQA volunteers to provide detailed and practical guidance to those auditors involved in the due diligence process.

Contents

1. An Introduction to Due Diligence
2. General Due Diligence Considerations
3. Due Diligence Agreements
4. Specific GxP Sections
5. Post Due Diligence Activities
6. Acronyms/Glossary
7. Appendix 1 - Checklist (GLP Example)
8. Appendix 2 - Example of Due Dilignce Request for Information

Authors

RQA Due Diligence Working Party

ISBN

978-1-904610-28-1

Published

April 2013

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Quality Risk Management has been produced by the QRM Working Party of RQA.

The Objectives of this document are to provide guidance for understanding quality risk management and to provide some practical examples of how this can be applied in different business areas and to a variety of processes.

Contents

1. Introduction
2. Principles of Quality Risk Management (QRM)
3. General QRM Process
4. Risk Assessment
5. Risk Control
6. Risk Communication
7. Risk Review
8. Implementing QRM in your Organisation
9. Worked Examples
10. Appendix 1 Glossary
11. Appendix 2 The Plan-Do-Check-Act (PDCA) Cycle
12. Appendix 3 Risk Management in Information Technology Projects

Authors

Rupinder Pannu and members of the RQA Risk Mangement Working Party.

ISBN

978-1-9046 10-10-6

Reprinted

April 2013

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The Quality Systems Guide is based on RQA’s Quality Systems Workbook; the aim of the guide is to provide guidance and support in the development of Quality Systems.

To gain the maximum benefit from this Quality Systems Guide, it should be read in conjunction with the RQA’s eLearning Course – Quality Systems

Contents

• Scope
• Introduction
• What is Quality?
• What does a Quality System normally include?
• To improve, where do I start?
• The Core Principles
• Managing
• Management of activities
• Managing organisations
• Influencing organisational management?
• What is a Quality System?
• What is the aim of a Quality System?
• What is the aim of your Quality System?
• Project planning software
• Planning
• Principles of planning
• Delivering
• Procedures and standards
• Standardising procedures
• Process flow
• Valid inputs
• Valid processes
• Valid outputs
• Computer systems
• Competence
• Measuring
• Quality Control (QC)
• Quality Assurance (QA)
• Inspection
• Feedback
• What comes next?
• Management review
• Summary

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Buy this booklet and receive a free electronic version of the booklet 'Guidelines for Quality in Non-Regulated Scientific Research'

Since the first publication of the Guidelines for Quality in Non-Regulated Scientific Research in 2006, the discovery landscape has exploded. Innovation truly abounds in all fields. This phenomenal advance has burst open the door of personalised medicine and diagnostics, as well as fuelled ethical and regulatory debate regarding its better use. Our advance in scientific understanding and capability is simply extraordinary. But with rapid advance comes risk. And when those simple checks and balances have been overlooked and research data is not fit for purpose, then negative consequences can be seismic in proportion. Little wonder then that institutions both large and small are recognising the wisdom of mitigating risk by introducing 'Quality' into their culture.

The aim of this updated Guideline is to facilitate the stepwise and straightforward development of a value-adding Quality System into any research institute. We have, in this second edition tailored our approach to help make the case for implementation essentially a 'no brainer'. In each section, we now review the risks posed by poor systems of work and exemplify, with real life examples or case studies, the consequences of non-robust research process. The potential steps which can then be taken to overcome such issues are highlighted, drawing on the original Guidelines as a basis, and then we indicate the additional benefits that good process often brings.

Contents

1. Editorial
2. Use of the guideline
3. Project management
4. Personnel
5. Facilities
6. Equipment
7. Materials and reagents
8. Assay validation
9. Procedures
10. Research and work records
11. Computerised systems
12. Research review
13. Quality system
14. References
15. Acknowledgements

Editors

Louise Handy and Steve Volsen

ISBN

1-904610-35-9

Published

September 2014

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The RQA Employment Survey 2017 Executive Report is now available for all RQA Members in the Members Area of the RQA website.

RQA Members CLICK HERE to purchase this ebook.  

The Executive Report highlights some of the key facts and figures from the RQA Employment Survey 2017; detailed findings and analyses are contained in the larger and more-detailed reports.

•  14% of employed respondents are unhappy or extremely unhappy with their job.
•  The average overall salary is in the “£60,001 to £70,000” bracket.
•  There is a difference between average Female and Male salaries.
•  The average recent bonus is in the “6% to 10% of salary” bracket. On average, the highest earners received the highest bonuses at “11% to 20% of salary”.

 The survey provides compelling data to show how people who scored high on job satisfaction also scored high on other aspects, such as salary, aspiration and inspiration.

 The results of the RQA Employment Survey 2017 are available in a range of formats:

•  A Summary Report detailing the key facts, figures and analyses (20 pages), is available to purchase from the RQA website.
•  A Full Report containing the facts, figures and analyses of all the survey questions (50 pages), is available to purchase from the RQA website.
•  A Complete Report, containing the Full Report and the complete dataset of responses in electronic (MS Excel) format, is available to purchase. Please contact the RQA office for details and price.

 Contents 

1. Introduction
2. Summary of key findings
3. The RQA membership survey findings
4. About you
5. Members in employment
6. Members in self-employment
7. Members in retirement
8. Annex one – List of graphs and charts
9. Annex two – Survey questions

RQA Member: USD ($) 218.72
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Your Price: USD ($) 61.58

The RQA Employment Survey 2017 Executive Report is now available for all RQA Members in the Members Area of the RQA website.

RQA Members CLICK HERE to purchase this ebook. 

The Executive Report highlights some of the key facts and figures from the RQA Employment Survey 2017; detailed findings and analyses are contained in the larger and more-detailed reports.

•  14% of employed respondents are unhappy or extremely unhappy with their job.
•  The average overall salary is in the “£60,001 to £70,000” bracket.
•  There is a difference between average Female and Male salaries.
•  The average recent bonus is in the “6% to 10% of salary” bracket. On average, the highest earners received the highest bonuses at “11% to 20% of salary”.

 The survey provides compelling data to show how people who scored high on job satisfaction also scored high on other aspects, such as salary, aspiration and inspiration.

 The results of the RQA Employment Survey 2017 are available in a range of formats:

•  A Summary Report detailing the key facts, figures and analyses (20 pages), is available to purchase from the RQA website.
•  A Full Report containing the facts, figures and analyses of all the survey questions (50 pages), is available to purchase from the RQA website.
•  A Complete Report, containing the Full Report and the complete dataset of responses in electronic (MS Excel) format, is available to purchase. Please contact the RQA office for details and price.

 Contents 

1. Introduction
2. Summary of key findings
3. Members in employment
4. Members in self-employment
5. Members in retirement

RQA Member: USD ($) 2692.60
Non-Member: USD ($) 218.72

Your Price: USD ($) 218.72

RQA Members CLICK HERE to purchase this ebook.

As organisations continually strive to improve quality and reduce risk, many are beginning to understand the benefits of preventive action.

The International Organisation for Standardisation (ISO) defines preventive action as “action to eliminate the cause of a potential nonconformity or other potential undesirable situation”. ISO also notes that there may be more than one cause of nonconformity.

Historically, organisations have performed root-cause analyses after an adverse event occurred in an attempt to understand why the event happened. With a focus on quality, safety, and risk-reduction, it is important to analyse products, processes and services to see what could go wrong before the adverse event occurs. Such analysis requires a rigorous methodology.

FMEA, or Failure Mode Effects Analysis, is an efficient method of identifying the cause of an adverse event before it occurs and can be the foundation of an effective prevention and improvement programme. Creating the opportunity to see potential errors and mistakes at the design stage saves time, money and, in extreme circumstances, lives. FMEA should not be a chore; it should be a voyage of discovery.

Contents

Introduction to FMEA

Introduction
Purpose
Benefits
History
Safety Factor

Types of FMEA

Concept FMEA
Product Design FMEA
Process FMEA

Conducting FMEA

Forming the Team
Points to consider
Adapting Accordingly
Completing the FMEA Chart
Conducting the FMEA
Rating the Effects
Summary

Case Study: Where is it?

Introduction
Before the FMEA
The FMEA
The benefit

Annexes

Annex 1 – FMEA chart
Annex 2 – Severity rating criteria
Annex 3 – Probability rating criteria
Annex 4 – Detection rating criteria
Annex 5 – Corrective action report

About RQA

Author

Anthony Wilkinson, RQA

Published

February 2018

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Guidance on audits of third parties and related activities was perceived as an obvious gap in RQA's booklet portfolio and therefore in April 2008, the Publications Committee commissioned a booklet with the aim of providing guidance to new auditors, or to those inexperienced in the outsourcing process and in undertaking audits of third parties. As well as presenting the key elements of a competent outsourcing process and the role of Quality Assurance (where applicable), this publication identifies specific items and broad pointers for preparation of checklists for the audit/assessment of suppliers across all GxPs.

Contents

1. Introduction
2. Outsourcing in Business
3. Vendor Audit Process
4. Audit Components
5. Specific GxP Considerations
6. Service Management
7. Bibliography and Further Reading

Authors

Caroline Bradshaw, John Dixon, Jo20y Eldridge, Sarah Howard, Angela Jennings, Kieran O'Donnell, Trev Simmons, Dympna Starling and Claire van Leersum

ISBN

978-1-904610-25-0

Published

March 2013

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Regulatory requirements for veterinary clinical studies have developed over the last 24 years. This paper covers the current best practice for the clinical study monitor. The monitor carries out a key role in clinical studies that is not sufficiently recognised; they may be active in all aspects of a clinical study. It is the purpose of this paper to describe and qualify these activities as outlined in the VICH GCP guidelines that currently represent best practice for clinical study performance.

This document is based on and develops the guidance found in VICH GL9, it should be noted that there are specific requirements and terminology, in for example, the Food and Drugs Administration's Code of Federal Regulations (CFR), CVM Guidance Documents, in EU Directives and EMEA guidelines that may be applied to veterinary clinical studies. The reader is directed to their national legislation for consideration of these items. This is of particular importance in the United States where the FDA may audit clinical studies against the detail of the appropriate CFR. No regulatory inspection for veterinary clinical study practice is carried out in the EU.

Contents

1. Monitor Training and Qualifications
2. Protocol, Case Report Forms and the Final Study Report
3. Amendments, Deviations and Notes to File, Data Quality Control, Clean up and Review
4. Investigator, Site and Laboratory Selection
5. Investigational and Control Veterinary Products, Adverse Events and Pharmacovigilance
6. Compliance with Standard Operating Procedures, Protocol and Good Clinical Practice
7. Monitoring Visits and Visit Reports
8. Quality Assurance
9. References
10. Glossary
11. Web Links for Reference to GCP for Veterinary Studies
12. Publications
13. Appendix 1: Example of Instructions to the Investigator
14. Appendix 2: Example of Personnel Signature Form
15. Appendix 3: Example of Pre-Study Training Form
16. Appendix 4: Example of Investigator Checklist
17. Appendix 5: Example of Study Site Checklist
18. Appendix 6: Example of Clinical Laboratory Checklist
19. Appendix 7: Example of Site-Closure Checklist

Authors

RQA Animal Health Committee and SQA Animal Health Speciality Section

ISBN

978-1-904610-26-7

Published

March 2013

RQA Member: USD ($) 29.73
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