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Good Laboratory Practice Online
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GLP Online | Good Laboratory Practice Course

Good Laboratory Practice

The Good Laboratory Practice (GLP) course provides an essential grounding in the way all types of non-clinical health and environmental safety studies should be planned, performed, monitored, recorded, archived and reported. The author, Roger Chapman is an internationally recognised expert in the interpretation and application of OECD Good Laboratory Practice to the full spectrum of regulatory studies, both in the laboratory and in the field. He has also led or participated in over 70 regulatory inspections from the MHRA, FDA and EPA, and has developed and maintained GxP quality systems and audit programmes for over 30 years. Updated: August 2016.

  • Average study time:
    study time

    6 hrs

  • Personal development points (CPD):
    points

    6 points

  • Price:
    points

    £69.00

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Course Details

Good Laboratory Practice (GLP) applies to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. The test items are often synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms.

This course is recommended for Principle Investigators, Study Directors, Managers and Quality Assurance staff plus all laboratory staff in testing facilities. It covers the internationally recognised OECD GLP principles that have been passed into law by the European Union and many other countries.

Benefits for you

  • CPD Points - Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
  • Certification - Receive a personal certificate to show your subject knowledge on course completion.
  • Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
  • Flexibility - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
  • Keep Up to Date - You will stay up to date with any legislative changes in GLP as our training courses are constantly monitored, reviewed and updated.
  • Learn from Industry Experts - The course content has been developed to ensure that you comply with GLP legislation through the application of learning outcomes. The course is written by Roger Chapman, internationally recognised expert in the application of OECD GLP principles and Quality Assurance systems.

Course Syllabus

1 - The History & Purpose of GLP

1.1 - Background

1.2 - The FDA investigation into IBT

1.3 - GLP is born

1.4 - What is GLP?

1.5 - Why do we need GLP?

1.6 - The evolution of GLP

1.7 - The role of The OECD

2 - Test Facility Organisation & Personnel

2.1 - Overview

2.2 - Management responsibilities I

2.3 - Management responsibilities II - Test facility management

2.4 - Management responsibilities III - Test site management

2.5 - Study Director responsibilities

2.6 - Principal Investigator responsibilities

2.7 - Study Personnel responsibilities

3 - Quality Assurance

3.1 - Overview

3.2 - Study plans, SOPs and the master schedule

3.3 - Inspections

3.4 - Final reports

3.5 - Reporting QA findings

3.6 - The QA statement

3.7 - Test facility & test site QA differences

 

4 - Facilities

4.1 - Overview

4.2 - Test system facilities

4.3 - Facilities for handling test & reference items

4.4 - Archive facilities

4.5 - Waste disposal

 

5 - Apparatus, Materials & Reagents

5.1 - General requirements I - Apparatus

5.2 - General requirements II - Materials

5.3 - General requirements III - Reagents

5.4 - Fitness for purpose

5.5 - Computerised system validation

 

6 - Test Systems

6.1 - Overview

6.2 - Physical/chemical test systems

6.3 - Biological test systems I - Health status

6.4 - Biological test systems II - Identification

6.5 - Biological test systems III - Sanitisation

6.6 - Biological test systems IV - Separation

 

7 - Test & Reference Items

7.1 - Definitions

7.2 - Receipt, handling, sampling & storage

7.3 - Characterisation

7.4 - Reserve samples

 

8 - Standard Operating Procedures

8.1 - General requirements

8.2 - Expected coverage

8.3 - Deviations

 

9 - Performance of the Study

9.1 - Overview

9.2 - Content of the study plan

9.3 - Amendments

9.4 - Deviations

9.5 - Raw data I - Overview

9.6 - Raw data II - Requirements

 

10 - Reporting of Study Results

10.1 - Overview

10.2 - Content of the final report

10.3 - Amendments I - Overview

10.4 - Amendments II - Additional work

10.5 - Amendments III - Reformatting

 

11 - Storage & Retention of Records & Materials

11.1 - Overview

11.2 - Retention periods

11.3 - Submission to the archive

11.4 - Retention

11.5 - Disposal & transfer

11.6 - Electronic data

 

12 - Additional OECD GLP Consensus/Advisory Documents & Position Papers

12.1 - Overview

12.2 - Suppliers

12.3 - Field studies

12.4 - Short-term studies

12.5 - Computer systems

12.6 - Sponsors

12.7 - Multi-site studies

12.8 - In-vitro studies

 

13 - GLP Programmes

13.1 - Overview

13.2 - Inspection Types I - Prospective membership

13.3 - Inspection Types II - Full membership

13.4 - Inspection Types III - Study audits

 

14 - Mutual Acceptance of Data

14.1 - Overview

14.2 - MAD & GLP

 

15 - Glossary & Bibliography

 

 

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