Pharmaceutical Microbiology Training
About This Course
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 virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. 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.
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 “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
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
Course Tutors
Ian Harwood – Ian is a GMP Consultant with over 20 years’ industry experience, including extensive knowledge of Pharmaceutical Quality Systems and GMP for steriles, biotech, IMPs, radiopharmaceuticals and unlicenced medicines. He spent 8 years as a GMP Inspector with the MHRA and is eligible to act as a Qualified Person.
Tony Mayhall - Tony is a biologist and has held a number of quality and operational roles for a variety of pharmaceutical organizations. His expertise is in auditing and manufacturing liquids and oral solid doses for both specials and commercial pharmaceutical products.
Gavin Halbert - A pharmacy graduate, QP and professor at the University of Strathclyde, Gavin was appointed as Director of the Department of Pharmaceutics’ Formulation Unit in 1992 with a role to formulate and manufacture anti-cancer drugs accepted by CRUK for use in human clinical trials.
Gavin teaches at both the undergraduate and postgraduate level in the areas of pharmaceutics, biopharmaceutics, pharmacokinetics and pharmaceutical microbiology.
He is a co-researcher in the EPSRC Centre for Continuous Manufacturing and Crystallisation and the EU Innovative Medicines Initiative for the Development of Novel Oral Biopharmaceutical Tools (OrBiTo).
Ian White – Ian has broad experience of the pharmaceutical industry. Most recently he worked as an Expert GMDP Inspector for the UK competent authority, the MHRA, where he was responsible for developing and implementing technical and policy-based aspects of the Inspectorate work, to reduce risk and improve the quality of medicinal products for patients. He led deployment-based operations for the roll-out of COVID vaccines, therapeutics, and anti-viral medicines, working across both government and industry to ensure robust supply chains, develop policy and provide sound, pragmatic, quality risk-based guidance.
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.
Discounts
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Qualified Person Training With NSF
Watch the video
A-Z of Sterile Products Manufacture
Pharmaceutical Formulation and Processing
Additional Recommended Courses
The Role and Professional Duties of the Qualified Person
This intensive, interactive training course is designed to provide aspiring QPs and other pharmaceutical quality professionals with the knowledge and understanding they need of the legal duties of the QP and, more importantly, how the QP must work with others to ensure that those duties and responsibilities are performed in the best interests of the company, the patient and society.
This course will help you to understand what the QP must do themselves and what can/must be delegated to others, it will provide advice on how the QP should work in tandem with professionals in other departments, and will stress the non-technical “people” skills that are essential to being a good QP.
Tutors: To be confirmed
Price: £2520 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).
Mathematics and Statistics
There are many training courses on statistics and statistical analysis, but very few which focus specifically on the application of these techniques to pharmaceutical manufacture and control. This is one such course! Designed to meet the needs of the aspiring Qualified Person and other pharmaceutical professionals and taught by a combination of statisticians and pharmaceutical industry professionals, this highly participative four-day mathematics and statistics pharmaceutical training course will teach you how to use statistical techniques to assess and monitor the reliability and accuracy of data you generate and the capability and reliability of the processes you work with. A pharmaceutical statistics course like no other! This virtual blended training course will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. This will require an element of learning to be completed prior to the virtual classroom, as well as afterwards and this will be managed through our online Learning Management System. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.
Tutors: To be confirmed
Price: £3160 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).
Analysis and Testing
This highly focused, intensive four-and-a-half-day course, taught by leading scientists and former Quality Control Managers, is designed to provide the aspiring Qualified Person or pharmaceutical quality professional with the knowledge and understanding they need to be able to perform their duties with skill and competence when interacting with the Quality Control laboratories.
We will explain to you the strengths and limitations of analysis and specific analytical methods, we will advise you on how to apply the principles of quality management and GMP to the testing environment in a pragmatic, effective way, and we will advise you of the very latest “hot topics” with the regulators and how to ensure that your laboratories are in compliance.
This virtual blended training course will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. This will require an element of learning to be completed prior to the virtual classroom, as well as afterwards and this will be managed through our online Learning Management System. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.
Tutors: To be confirmed
Price: £3555 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).