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Quality Assurance for Good Laboratory Practice REMOTE LEARNING


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

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

 

Recent Feedback

"Very engaging, considering that she was remote I was very impressed with the flow and detail."
"Both Roger and Jane were enthusiastic speakers with extensive knowledge and experience about Quality Assurance in the real world."
"Very knowledgeable, had a lot of real life experiences to draw on. Flexible approach to timetable. Paced information about right, happy to answer questions." 

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. 

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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

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 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

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