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About us
Quality Assurance for Good Laboratory Practice
Course Information
A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme.
What will I learn?
- A solid regulatory foundation underpinning quality assurance activities
- Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles
- Enhanced efficacy in inspections and audits
- Heightened compliance with Good Laboratory Practice standards for your facility
- Unique insights into governmental monitoring activities within the GLP sphere.
This course is structured to encourage delegates to
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Discuss and develop ideas
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Solve specific problems
- Examine particular aspects of GLP.
Tutors
Tutors will be comprised of (click the photos for biographies):
Cate Ovington
Cate Ovington has over 20 years of experience in Quality Assurance across GLP, GCP (specialising in laboratories), non-regulatory research and computer system validation. Working in diverse organisations, from small to international CROs and academia, and latterly as a consultant working internationally. Cate has experience in performing internal audits, leading audit teams, and performing external audits remotely and on-site.
Jane Elliston
Jane Elliston currently works for Battelle UK as a senior quality assurance auditor in GLP AgroChemical Residue and Environmental Fate Studies after more than 4 years as a consultant offering QA services in GLP, GCLP, GCP, GMP, ISO 9001, ISO 17025.
In her current role Jane conducts independent audits of facilities, studies and reports, and conducts customised training for staff.
Jane is a regular contributor to RQA Course and Conferences and received the RQA Award for Contribution to Industry in 2017.
Shona Ross
With almost 20 years experience in research, development and manufacturing, Shona leads the QA and audit programmes for Tower Mains portfolio of quality offerings. With a strong data integrity background across regulatory areas, Shona’s primary focus is laboratories and using audits and training to support Sponsors and Clients locally and globally.
Shona is presently a member of the GLP Committee and has previously served on the Animal and Veterinary Product Committee.
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Welcome and Introductions
09:30
Good Laboratory Practice Standards and Regulations
An insight into the background and history of Good Laboratory Practice, regulations and the OECD Mutual Acceptance of Data.
10:00
Definitions in GLP
Overview of terminology used in GLP and what they mean.
10:25
Break
11:00
Principles of Quality Assurance
The role and responsibilities of QA in GLP. Maintaining the independence of QA.
11:40
Standard Operating Procedures
GLP requirements and QA involvement.
12:10
Study Plans
GLP requirements and QA involvement.
12:50
Lunch
13:30
Workshop 1 - Study Plan Review
14:00
Workshop 1 - Feedback
14:15
QA Programme
Facility, Study and Process Audits. How to design an audit programme.
15:00
Audit Planning
How to prepare for an audit, creating and using checklists.
15:30
Break
15:45
Workshop 2 - Audit Preparation
An exercise in inspection planning and preparation for an audit.
16:15
Workshop 2 - Feedback
16:30
Audit Conduct
How to prepare and conduct the audit.
16:45
Panel Session
An opportunity for delegates to put questions to the panel of speakers
17:00
Close of day
Day 2
09:00
Reporting of Audit Findings
What the audit report should include, how to write findings.
09:45
Workshop 3 - A Mock Audit
Performing an audit using documents and evidence.
11:45
Workshop 3 - Feedback
12:15
Record Keeping and Data
Requirement of data and records management including electronic data and data integrity.
13:00
Lunch
13:45
Auditing the Study Report
Techniques and methods for the QA audit of the study report.
14:30
Workshop 4 - Auditing Data
Auditing Data, using checklist/audit guides
15:15
Workshop 4 - Feedback
15:35
Regulatory and External Inspections/Audits
Hosting and managing external inspections/audits.
16:00
Panel Session
An opportunity for delegates to put questions to the panel of speakers
16:30
Close of course
Extra Information
Course Material
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
Please note this course will run in UK timezone.
The advantages of this include:
- Ability for delegates to keep material on a mobile device
- Ability to review material at any time pre and post course
- Environmental benefits – less paper being used per course Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
Course Material
Course material will be available in PDF format for delegates attending this course. The advantages of this include:
- Ability for delegates to keep material on a mobile device
- Ability to review material at any time pre and post course
- Environmental benefits – less paper being used per course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
CPD Points
14 Points
Development Level
Learn
Recommended Products
A Practical Guide to GLP Quality Assurance eBooklet
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory eBooklet
Guide to the Role and Responsibilities of GLP Management eBooklet
Hosting an External GLP Inspection eBooklet
Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to the Audit Process elearning
Management of the Training and Competency of Personnel in GxP and Research Environments eBooklet