91AV

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Pharmaceutical Microbiology - QP Module

13 May 2019 08:30 - 17 May 2019 12:00, York, United Kingdom


Introduction
A highly interactive four-and-a-half-day pharmaceutical microbiology training course designed to provide the aspiring Qualified Person and pharmaceutical quality professionals with the knowledge and understanding they need to be able to assess microbiological risks in the pharmaceutical manufacturing environment, to assist in the design and implementation of comprehensive microbiological control strategies and to take informed decisions when microbiological problems occur.

Microbiological contamination of products and processes continues to be a major concern to the industry and its regulators. The potential impact of such contamination can be catastrophic. Put simply, microbial contamination can kill your patients and your business! This course, for both non-biologists and microbiologists, is designed to provide you with the knowledge, confidence and decision making risk assessment skills to prevent this happening.

This course is approved by the 91AV as suitable for their members’ continuing professional development.

Key Learning Objectives
On completion of this course delegates will know and understand:
  • The basic characteristics of all microorganisms found in your premises – how they get there and how you can remove them
  • 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
  • Microorganisms
  • Micro methods
  • Microorganisms and your products, procedures and plants
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

Who Should Attend
The Aspiring Qualified Person
Our training is generally considered as the best available and our QPs are held in high regard within the industry.

As well as being accepted in the UK, our training courses are well known and accepted by several other 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!

The Pharmaceutical Technical Professional
Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within 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. Taken with some of our other QP modules, this course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications.

Find out why you should choose NSF for your QP training by visiting our qualified person training section. 
 
Venue
York Marriott

York Marriott, Tadcaster Road, Dringhouses, York, YO24 1QQ, United Kingdom

Contact information
Aimee Harding
NSF Health Sciences
+1751 432999
Contact us by email

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