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GLP for Study Directors, Principal Investigators, Study Staff and Management

A 10% discount will be available against this course when booked along with a Full Conference Delegate package. To take advantage of this discount, please add all items to your basket and enter PRECON as the discount code at the checkout. 
This can also be booked as a stand alone course.

Course Information

This course is designed to provide comprehensive guidance and practical help for those who fulfil the role of Study Director or Principal Investigator in the conduct of non-clinical safety studies on pharmaceuticals, agricultural and industrial chemicals in compliance with Good Laboratory Practice. This course will also be of considerable benefit to study staff and management working in a GLP environment. The course will address current OECD GLP Principles and UK GLP legislation, but will also make reference to other international standards, regulations and guidelines.

Benefits include

  • Practical help and guidance on the interpretation and application of GLP
  • An opportunity to update your knowledge of GLP with the current interpretation of requirements
  • Access to an experienced panel of speakers
  • Information on how other organisations address GLP issues
  • An opportunity to improve your understanding of the GLP requirements as they are applied in different situations

This course is structured to encourage delegates to

  • Discuss and develop ideas
  • Solve specific problems
  • Examine particular aspects of GLP
  • Learn from the experience of others

Course Tutors

Tim Stiles
Regulatory Compliance Consultant, Qualogy Ltd (Course Principal)

Vanessa Grant
Director of Quality Assurance, Envigo
 
Jeanet Logsted
Director of Toxicology Operations, CiToxAB Scanto
 
Lynsay Hunter
MHRA

Recent Feedback

"Loved the conversational style (experienced instructors know how to use powerpoint to aid a presentation rather than relying on it) and the consistent inclusion of just enough humour to keep us engaged without being overbearing. "

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.

Accommodation

Hotel accommodation is not included in the course fees. Accommodation should be booked direct with hotels in Edinburgh. The following link will take you to a number of hotels where special rates have been negotiated. This is a service not run by RQA. http://www.successfuleventslive.co.uk/5th_Global_QA_Conference_2017

Day 1

9.00 Registration
9.15 Welcome and Introductions
9.35 Development of Good Laboratory Practice
A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards
10.05 Roles and Responsibilities
The responsibilities of Study Director, Test Facility Management and study staff in the conduct of a GLP study
10.45 Break
11.00 The Roles and Responsibilities of the Study Director and Test Facility Management
The role of the Study Director in the management and control of a study, as defined by GLP, and Managements roles are explored
11.45 Multi-site Studies
What is a multi-site study and when should such concepts be applied on a study. The role of the Study Director and Principal Investigator in the planning, conduct and reporting of multi-site study are explored
12.30 Study Plans (Protocols) 
GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed
13.00 Lunch
13.45 Workshop 1 – The Study Plan
Some practical problems with study plans and amendments explored
14.45 Workshop 1 – Feedback
15.00 Standard Operating Procedures
The control, content and authorisation of SOPs and the principles behind the practice
15.30 Break
15.45 Workshop 2 - Practical Study Conduct Problems
Dealing with practical problems encountered during the conduct of studies
16.40 Workshop 2 – Feedback
17.15 Close of day

Day 2

9.00 Questions and Answers
Discussion of issues raised by course delegates
9.20 Quality Assurance
The interactions between QA, Management, Study Director and Principal Investigator are discussed
10.00 The Final Report
The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained
10.30 Break
10.45 Workshop 3 - Final Report Problems
Practical problems of report preparation including compliance statements
11.30 Workshop 3 – Feedback
12.00 Management of Raw Data and Records
A view on how records and materials are managed and archived in compliance with GLP
12.45 Lunch
13.30 Workshop 4 - Data and Sample Management Issues
Dealing with data and sample management issues
14.15 Workshop 4 – Feedback
14.45 Regulatory Inspection
Government monitoring for compliance with Good Laboratory Practice
15.15 Panel Session
This panel session will address any outstanding issues raised by delegates
15.45 Close of course

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Recommended Products

Annual Conferences

RQA Global Conference 2017 - Edinburgh (1st Nov 2017 - 3rd Nov 2017 )

Booklets

Guide to the Role and Responsibilities of GLP Management Booklet
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

C8053 GLP for Study Directors, Principal Investigators, Study Staff and Management (5th Sep 2017 - 6th Sep 2017 )
C8055 GLP for Study Directors, Principal Investigators, Study Staff and Management (20th Feb 2018 - 21st Feb 2018 )
C8056 GLP for Study Directors, Principal Investigators, Study Staff and Management (Copenhagen) (21st Nov 2017 - 22nd Nov 2017 )
C8141 GCP Regulatory Inspections (30th Oct 2017 - 31st Oct 2017 )

eLearning Products

Advanced Good Laboratory Practice (GLP) elearning
Introduction to Good Laboratory Practice (GLP) elearning

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