Good Laboratory Practice Refresher REMOTE LEARNING

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Programme
Extra information

RQA CPD Stamp

REMOTE LEARNING - this course will be delivered to you live online from the UK.

Course Information

The course is aimed at providing a reminder and refresh insight of the key GLP requirements and responsibilities including Data Integrity and also to look at recent hot topics and trends including feedback from MHRA Inspections. Specific areas covered include Risk Assessment and the OECD guidance on Sponsor Influence. The programme also includes a GLP clinic where any issues raised by the delegates regarding understanding and maintaining GLP Compliance can be discussed.

The course is aimed at Study Directors, Principal Investigators, Test Facility Management and QA.

Course Tutors

Tutors will be comprised from the list below:

Tim Stiles
Regulatory Compliance Consultant, Qualogy Ltd

Vanessa Grant
Associate Director, AstraZeneca

Recent Feedback

"Vanessa presented her story really clear and responded nice and directly on questions. Especially the examples from her own experience helped a lot to clarify the information received / the questions asked. The different exercises on Data Integrity (though not always directly clear from the start) were a really nice variety with listening to the story. If possible, more exercises would help to maintain concentration. Nevertheless, it was really nice to have Vanessa as a tutor."
"It is very informative and with good discussion."
"Topics of OECD nr 19 were described and discussed. Especially the different examples were very helpful."

CPD Points

7 Points

Course Programme

Please note this course will run in UK timezone.

9.00	Registration
	Welcome and Introduction
9.15	Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards as well as possible impact of Brexit.
9.45	Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the role of the Study Director in the management and control of a study, as defined by GLP, and Management’s roles are explored.
10.30	Break
11.00	Data Integrity With the publication of the MHRA Guidance document on Data Integrity has the challenge changed? The responsibilities of Study Director, Test Facility Management and study staff in ensuring the integrity of the GLP study data. Including exploring the practical issues of assuring data integrity.
11.45	Influence of Sponsors The recently published OECD Position Paper Number 21 regarding Possibly Influence of Sponsors on Conclusions of GLP Studies is reviewed and discussed..
12.45	Lunch
13.45	Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings.
14.15	Test Item Requirements What are the new requirements from OECD No.19 and what are the expectations on the Study Director /Principal Investigator and Test Facility Management.
14.35	GLP Clinic A chance to discuss your own issues.
15.15	Break
16.00	Current Hot Topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings
16.30	Close of day

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.

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