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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.
09:45
Principles of Quality Assurance
What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit.
10:30
Break
10:45
Standard Operating Procedures
GLP requirements and QA involvement.
11:30
Study Plans
GLP requirements and QA involvement.
12:05
QA Programme
Risk based programme, what are study, process and facility audits.
13:00
Lunch
14:00
Inspections
Attitudes, techniques and attributes.
14:40
Workshop 1 - Facility and Process Inspections
An exercise in inspection planning and preparation for inspections.
15:15
Break
15:30
Workshop 1 - Feedback
15:45
The Auditor and Audit Conduct
Attitudes, attributes and techniques.
16:30
Panel Session
An opportunity for delegates to put questions to the panel of speakers.
17:15
Close of Day
Day 2
09:00
Workshop 2 - A Mock Audit
10:45
Break
11:00
Workshop 2 - Feedback
11:30
Auditing the Study Report
Techniques and methods for the QA audit of the study report.
12:00
Record Keeping and Data
The impact of GLP on data and records management.
12:40
Lunch
13:25
Data Integrity
A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value.
14:15
Workshop 3 - Amendments to Study Plan and Deviations from the Plan
What are they? What is the difference between them? How are they controlled?
15:00
Workshop 3 - Feedback
15:15
Break
15:30
Regulatory Compliance
GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice.
16:15
Panel Session
An opportunity for delegates to put questions to the panel of speakers.
16:45
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