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Research Quality Assurance for Good Laboratory Practice

Get 10% off this course with the code: QAFORGLP

(only valid on 2nd - 3rd April 2019 dates)

RQA CPD Stamp

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:

Roger Chapman
Director, Chapman QA Ltd (Course Principal)

Jane Elliston
Quality Consultant, Headway Quality Evolution

Christina Olsen-Sundelin

MHRA

Recent Feedback

"The tutors were very engaging fun to watch, added their own experiences to prove a point or back up the course information."
"Excellent course, Excellent staff rolling out the training. Very experienced and could give you industry examples from their own experiences to help understand or further the understanding and knowledge from the course material."

CPD Points

14 Points

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.

Additional Requirements
(not included in course fees)

Accommodation is available at Madingley Hall for the dates of the course. If you wish to book alternative dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall.

Course Programme

Please note timings may be subject to alteration

 

Day 1 

8.55 Registration 
 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 (1)
The role and responsibilities of QA. 
 10.30 Break 
 10.45  Principles of Quality Assurance (2)
The role and responsibilities of QA. 
 11.30 Study Plans
GLP requirements and QA involvement. 
 12.05 Standard Operating Procedures
GLP requirements and QA involvement. 
 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 - continued 
 16.15 Workshop 1 - Feedback 
 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. 
 12.15 The Management of Raw Data, Record Keeping and Training Records (1)
The impact of GLP on data and records management.
The use of computers in a GLP environment. 
 12.45 Lunch 
13.30  The Management of Raw Data, Record Keeping and Training Records (2)
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
Government 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 day 
   
   
   
   
   
   
   
   

 

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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
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting

eLearning Products

Introduction to GLP Study Director Roles and Responsibilities
Introduction to Good Laboratory Practice (GLP) elearning
Introduction to the Audit Process elearning

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