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International QA Conference 2023, Belfast
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About us
Quality Assurance for Good Laboratory Practice
If you are wanting to book more than one person onto a course(s) please email courses@therqa.com
For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - courses@therqa.com in the first instance
Course Information
This course is essential for all Quality Assurance auditors just stepping out or developing their role in a GLP environment, and provides expert insight and guidance in developing a robust and effective GLP audit programme.
Benefits include
- Sound regulatory basis for quality assurance activities
- Clear understanding of the role of Quality Assurance, Management and Study Director under the Good Laboratory Practice principles
- Improved inspections and audits
- Improved Good Laboratory Practice compliance for your facility
- An insight into government GLP monitoring activities
This course is structured to encourage delegates to
- Discuss and develop ideas
- Solve specific problems
- Examine particular aspects of GLP
Course Tutors
Tutors will be comprised from the list below:
Cate Ovington
Director, The Knowlogy (Course Principal)
Jane Elliston
Senior Quality Assurance Auditor, Battelle
Shona Ross
Head of QA, Tower Mains
Recent Feedback
"Thank you for some very good days with very good learnings."
"Excellent and experienced tutor! He was great at presenting, exercise facilitation and giving feedback. He encouraged us to think outside the box. He made the course very interesting. He was also very easy to engage with and very helpful."
"She is a great experienced tutor who shared a lot of her past experiences which we can learn from! She presented well and was indeed engaging. Easy to talk to and relate with."
CPD Points
14 Points
Course Programme
Please note timings may be subject to alteration
Day 1 |
|
| 9.00 | Welcome and Introductions |
| 9.15 | Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. |
| 9.45 | 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 |
|
| 9.00 | 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 |
Course Material
Following requests from attendees of previous RQA events we are pleased to offer course material 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.
You will also receive a copy of our booklet - "A Practical Guide to GLP Quality Assurance"
Additional Requirements
(not included in course fees)
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.
Recommended Products
Booklets
A Practical Guide to GLP Quality Assurance
A Practical Guide to Good Laboratory Practice in the Analytical Laboratory
Guide to the Role and Responsibilities of GLP Management
Hosting an External GLP Inspection
Management of the Training and Competency of Personnel in GxP and Research Environments
Courses
P01 Introduction to Computer Systems Validation
P05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP05 Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management REMOTE LEARNING
RP09 The Remote Auditing Course REMOTE LEARNING
RP16 Good Laboratory Practice Refresher and Hot Topics REMOTE LEARNING
RP34 Practical Approach to Auditing Systems and Processes REMOTE LEARNING
eLearning Products
Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to the Audit Process elearning
