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About us
Quality Assurance for Good Laboratory Practice REMOTE LEARNING
REMOTE LEARNING - this course will be delivered to you live online from the UK.
If you are wanting to book more than one person onto a course(s) please email courses@therqa.com
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
"I could easily follow his presentations and explanations. I liked very much how precisely and clearly he answered all questions, without big detours and digressions."
"I really liked Jane's understandable way of responding to participants' questions. I appreciated how easily she answered them, even for non-native English speaking participants. Her presentations were very easy to follow."
"This was a remote training but with no loss of information or communication with other colleagues and direct contact with the tutors. Workshops were provided with exercises that allowed exchange of doubts, experiences with other realities."
CPD Points
14 Points
Course Programme
Please note this course will run in UK timezone.
Day 1 |
|
| 9.00 | Welcome and Introductions |
| 9.20 | Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. |
| 9.50 | Principles of Quality Assurance (1) The role and responsibilities of QA. |
| 10.30 | Break |
| 10.45 | Principles of Quality Assurance (2) The role and responsibilities of QA continued. |
| 11.40 | Study Plans GLP requirements and QA involvement. |
| 12.15 | Standard Operating Procedures GLP requirements and QA involvement. |
| 13.00 | Lunch |
| 14.00 | Inspections Attitudes, techniques and attributes. |
| 14.45 | Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. |
| 15.15 | Break |
| 15.30 | Workshop 1 - continued |
| 16.00 | Workshop 1 - Feedback |
| 16.45 | Panel Session An opportunity for delegates to put questions to the panel of speakers. |
| 17.00 | Close of day |
Day 2 |
|
| 9.00 | Record Keeping and Data The impact of GLP on data and records management. |
| 9.45 | Auditing the Study Report Techniques and methods for the QA audit of the study report. |
| 10.30 | Break |
| 10.45 | Workshop 2 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? |
| 11.45 | Workshop 2 - Feedback |
| 12.15 | Lunch |
| 13.15 | Data Integrity An overview of industry expectations and the OECD draft guidance ... And a brief insight into the murky world of fraud, falsification, malpractice and various other points of view. |
| 14.15 | Covid-19 Considerations Maintaining compliance during this pandemic |
| 15.00 | Break |
| 15.15 | Regulatory Compliance Government monitoring for compliance with Good Laboratory Practice. |
| 16.15 | Panel Session An opportunity for delegates to put further questions to the panel of speakers. |
| 16.30 | Close of 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.
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
P04 Quality Assurance for Good Laboratory Practice
RP01 Introduction to Computer Systems Validation 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
