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Good Clinical Laboratory Practice Online
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GCLP Online | Good Clinical Laboratory Practice Course

Good Clinical Laboratory Practice (GCLP) Training for Laboratories, Manufacturers and Suppliers of Pharmaceutical products

The Good Clinical Laboratory Practice (GCLP) course describes the standards to be followed by laboratories that perform analysis or evaluation of clinical trial samples. The GCLP rules were produced because the GCP guidance contains little or no detail to provide specific guidance to clinical laboratories. The course covers all aspects of GCLP from the set up and planning of the analytical lab (based on the type and quantity of samples to be processed), right through to the documentation and analysis itself. The author, Louise Handy, is Chair of the RQA (formerly BARQA), who published the original GCLP guidance that is now recognized worldwide.

  • Average study time:
    study time

    6 hrs

  • Personal development points (CPD):
    points

    6 points

  • Price:
    points

    £89.00

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Course Details

Good Clinical Laboratory Practice (GCLP) is a crucial supplement to the broader GCP rules that govern clinical trials. The principles should be followed by all labs involved in analysing samples from clinical trials to ensure that the work is reliable, ethical and can accurately be used to support the findings of the trial.

This course is recommended for - lab managers, QA personnel, lab project managers, and other lab staff, plus senior management considering a move into clinical trials work within - clinical laboratories, university labs, pharmaceutical company labs, and hospital labs involved with clinical trials.

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 GCLP 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 GCLP legislation through the application of learning outcomes. The course is written by Louise Handy, who is a chairperson for the Research Quality Assurance (RQA)

Course Syllabus

1. Background to GCLP

·         1.1 What is Good Clinical Laboratory Practice?

·         1.2 Aren’t Clinical Trials Performed to GCP?

·         1.3 Why not use GLP?

·         1.4 The Origins of GCLP

·         1.5 UK Legislation & Guidance

·         1.6 EU Legislation & Guidance

·         1.7 Non-EU Legislation & Guidance

2. Facilities, Organisation, & Personnel

·         2.1 Facilities

·         2.2 Organisation - Introduction

·         2.3 Organisation – Laboratory Management

·         2.4 Organisation – Scientific Analysis

·         2.5 Organisation – Quality Assurance

·         2.6 Organisation – Reporting

·         2.7 Organisation – Archiving

·         2.8 Personnel

3. Contracts & Agreements

·         3.1 Contracts & Agreements

·         3.2 Agreements with Suppliers

4. SOPs & Instructions

·         4.1 Introduction

·         4.2 Standard Operating Procedures

5. Conduct of the Work

·         5.1 Planning

·         5.2 What if Activities Seriously Diverge from the Protocol, Plan or Contract?

·         5.3 What if Activities Diverge from Laboratory SOPs?

·         5.4 Activities & Processes I

·         5.5 Activities & Processes II – Forward Planning

·         5.6 Activities & Processes III – Security of the Chain

·         5.7 Activities & Processes IV – Maintaining Confidentiality

·         5.8 Activities & Processes V – Storage

·         5.9 Activities & Processes VI – Analysis 

·         5.10 Reporting

6. Patient Matters

·         6.1 Unexpected Results

·         6.2 Privacy

·         6.3 Informed Consent

·         6.4 Blinding

7. Equipment & Computerised Systems

·         7.1 Equipment

·         7.2 Computerised Systems

8. Quality Control

9. Quality Assurance and Audit

·         9.1 Introduction

·         9.2 Audit

10.   Archiving & Retention of Data

11. References and Links

12. Glossary

 

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