Approved training courses

Course description

Please note, the duration of this course is 4.5 days.

A highly interactive course designed to provide the aspiring QP and pharmaceutical quality professionals with the knowledge and understanding they need to be able to assess microbiological risks in the pharmaceutical manufacturing environment. By attending this course you will learn:
• The basic characteristics of all microorganisms found in your pharmaceutical environment, how they get there and how you can remove them
• How you can sample, isolate, count and identify these microorganisms
• How to prevent contamination of your products and processes using practical risk management and risk assessment tools and techniques
• How to interpret microbiological data in order to make the right ‘risk-based’ decisions – decisions that will satisfy the regulators, protect your patient and improve your operational efficiency

COURSE OUTLINE

Microorganisms: Understanding your ‘Enemy’!
• 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
• Process Analytical Technology (PAT)
• Rapid (non-culturable) methods
• The microbiology laboratory: Good Laboratory Practice
• Monitoring methods
Microorganisms: Your Products, Procedures & Plants
• Raw materials
• Contamination control strategies
• Microbiological aspects of good plant and process design
• How to use media fills to assess the vulnerability of your process to contamination
• How to use risk assessment and hazard analysis to identify and remove contamination risks
Microorganisms: How to Remove Them!
• Good sanitization practices
• The kinetics of sterilization
• Sterilization
• Antibiotics: How they work and how you test them
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 ‘failures’ on product quality and patient safety

Pre-requisites

Please speak to Aimee Harding, QP Administrator at NSF, about entry requirements for both QP training and/or postgraduate qualifications.

Additional info

Lunches and refreshments are included in the course fee plus a special 'course dinner' on the penultimate evening. Specially negotiated B&B rates are available. For further information please contact Aimee Harding, QP Administrator at NSF.

Venue

Jurys Inn

Teaching method

Class/lab

City

Brighton

Duration

5 day

Cost

£3330.00 GBP (plus VAT)

Training provider

NSF International

Email

qppharma@nsf.org

Tel

01751432999

Find an approved training course

Use the options below to search through the growing list of chemical sciences training courses that have been approved by the Royal Society of Chemistry.


Blended Learning
Class/lab
In-house
Online