外网天堂

Course description

Key Learning Objectives

On completion of this pharmaceutical microbiology course you will know and understand:

• The basic characteristics of all microorganisms found in your premises (how they get there and how to remove them)
• Microbiological methods
• How to sample, isolate and identify these organisms
• How to prevent contamination of your products and processes using risk management and assessment tools and techniques
• The interpretation of data
• QP decision making
• How to satisfy the regulator and protect your patient

Course Outline

Microorganisms: Understanding Your 鈥淓nemy!鈥�

• The physiology and key characteristics of microorganisms
• Routes of contamination

Microbiological Methods: How-to Guidance on:

• Sampling
• Isolation and enumeration (counting)
• Identification (how and when to identify microorganisms)
• Tests for sterility and preservative efficacy
• Rapid (non-culturable) methods
• Monitoring methods

Microorganisms: Your Products, Procedures and Plants

• Raw materials
• Contamination control strategies
• Microbiological aspects of good plant and process design
• How to use risk assessment and hazard analysis to identify and remove contamination risks

Microorganisms: How to Remove Them!

• Good disinfection practices
• Sterilisation and filtration

Decision Making and Problem Solving

• How to interpret microbiological data and trends
• How to identify the root cause of contamination incidents
• How to use risk assessment techniques to assess the impact of 鈥渇ailures鈥� on product quality and patient safety

Who Should Attend?

The Aspiring Qualified Person

• Our training is generally considered as the best available and our QPs are held in high regard in the industry.
• As well as being accepted in the UK, our training courses are well known and accepted by several EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
• You are more likely to become a QP with us than with any other training provider.
• Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications.

The Pharmaceutical Technical Professional

• Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers in other areas of pharmaceutical manufacture and control.
• Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.

Prerequisites

For any queries regarding entry requirements for both QP training and/or postgraduate qualifications please contact [email protected]

Additional information

NSF delivers instructor-led QP courses with blended training methods, in a mix of virtual and in-person courses. Please visit for further information. If you cannot see your delivery method of choice, please contact [email protected].