Qualified Person (QP) Training: Pharmaceutical Microbiology

Date :	in-house/on-demand
Cost :	£900
Location :	Web-based Distance Learning
Duration :	Self Paced available 24/7

Qualified Person (QP) Training: Pharmaceutical Microbiology.

This course provides a detailed overview of pharmaceutical microbiology and its impact on the quality of medicines produced.  Aimed primarily at trainee QP's who do not have a microbiological degree, the course will also provide qualified microbiologists with an appropriate appreciation of modern microbiology and how it is applied in a pharmaceutical environment.

The course is based on the QP Study Guide, but also includes additional topics to educate the QP of tomorrow.

The course consists of undertaking an on-line learning programme consisting of 10 study topics and suggested further reading. After each topic an exercise is submitted for review and feedback from the course tutor. Once all of the 10 units have been competed satisfactorily a detailed practical assignment is undertaken. Support and coaching will be available from the course tutor to assist in the completion of the assignment. If this is satifactory a Certificate is issued to indicate that this course has been completed successfully.

COURSE CONTENTS:

STUDY GUIDE REQUIREMENTS:

• Sources and types of micro-organisms as related to pharmaceutical production.
• Production of sterile and non-sterile products * and associated environmental controls.
• Bacterial endotoxins and pyrogens, their sources, removal and testing.
• Microbiology of water, its production and distribution systems.
• Sterilisation and disinfection methods.
• Interpretation of microbiological data.
• Validation of microbiological test methods.
• Microbiological specifications.
• Selection and use of preservatives.
• Microbiological test methods used in routine manufacture and product development.
• Rapid methods of microbiological testing.

     * Production of sterile and non-sterile products covered in more detail in Formulation and Processing module. 

PLUS, WE WILL ALSO COVER:

• Microbiological consideration for the manufacture of non-sterile products.
• Environmental monitoring.
• Microbiological monitoring of starting materials.
• Validation of aseptic processes.
• Microbiological assays.

PRICE:

£900.00 plus VAT.