Pharmaceutical Microbiology Training

This highly interactive, pharmaceutical microbiology course is designed to provide the aspiring Qualified Person and pharmaceutical professionals with the knowledge and understanding they need to assess microbiological risks in the pharmaceutical manufacturing environment. Learn how to assist in the design and implementation of comprehensive microbiological control strategies and how to make 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 pharmaceutical microbiology course is designed to provide both non-biologists and microbiologist with the knowledge, confidence and decision-making risk assessment skills to prevent this from happening.

Our in-person training includes many group exercises aligned to common microbiological scenario’s an aspiring QP may encounter and includes a half-day practical session where delegates will have the opportunity to practice fundamental techniques including environmental monitoring and identification techniques. Full details will be sent following registration.

This pharmaceutical microbiology course is approved by the Royal Society of Chemistry as suitable for their members’ continuing professional development.

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 including practical techniques
• 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: 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
• 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 “failures” on product quality and patient safety

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

Tamryn Hassel – Tamryn is an experienced, compliance-driven quality professional and MBA with over 16 years of progressive experience and a proven record of significant and successful contributions in Pharmaceutical Management Systems. She was part of a global team leading investigations on the COVID vaccine supply chain and was responsible for the setup of a QC Microbiology site of excellence.

Samantha Clack – Samantha has worked in the pharma industry for over 20 years, and has been an active QP at licensed packing facilities for over half that time. Also an experienced auditor, Samantha has audited packaging facilities worldwide.

A Guest Lecturer from the University of Strathclyde will present on this module.

Multi-delegate discounts available. Discounts also offered to NHS staff and charities.