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Quality Assurance for Good Laboratory Practice
- 30 Day Money Back Guarantee
- Completion Certificate
- 24/7 Technical Support
Highlights
Delivered In-Person
Description
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
Discuss and develop ideas
Solve specific problems
Examine particular aspects of GLP.
Tutors
Tutors will be comprised of (click the photos for biographies):
Cate Ovington
Director, The Knowlogy Group Ltd
Jane Elliston
Senior Quality Assurance Auditor, Battelle UK
Shona Ross
Head of QA, Tower Mains Ltd
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Welcome and Introductions
09:15
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
Face-to-face course
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.
Remote course
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.
CPD Points
14 Points
Development Level
Learn
Location
Madingley Hall University of Cambridge Institute of Continuing Education, CB23 8AQ, United Kingdom, CambridgeAbout The Provider
Research Quality Association
Ipswich
RQA (Research Quality Association) is the global community for QA professionals, providing invaluable information, education, and networking opportunities
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