Mathematics and Statistics Training
About This Course
There are many training courses on statistics and statistical analysis, but very few that focus specifically on the application of these techniques to pharmaceutical manufacture and control. This course does.
Taught by statisticians and pharmaceutical industry professionals, our four-day course is designed to meet the needs of the aspiring Qualified Person (QP) and other pharmaceutical professionals. The highly participative training teaches you how to use statistical techniques to assess and monitor:
- The reliability and accuracy of data you generate
- The capability and reliability of the processes you work with every day
The pharmaceutical industry has historically underutilized the same statistical data analysis techniques many other industries have extensively used to drive product and process improvement. Even today, the pharmaceutical industry could still be characterized as data rich but information poor.
The provision of useful information is essential. That is why we created this pharmaceutical mathematics and statistics training course.
Recent developments in global Good Manufacturing Practice (GMP) guidelines are urging pharmaceuticals to catch up with other industries by placing greater emphasis on the trending of data. This applies to EU and U.S. requirements for ongoing process verification as part of process validation, product quality reviews, ICH Q10 and more. The ability to analyze and trend data is now an essential survival skill. This pharmaceutical training course shows you how to do this simply and effectively.
Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced learning online. Full details will be sent to you following registration.
This course is approved by the Royal Society of Chemistry as suitable for its members’ continuing professional development.
Key Learning Objectives
At the end of this course, you will understand how to:
- Assess the reliability and accuracy of data and information arising from samples taken from a population, using techniques such as:
- Basic statistics: mean, standard deviation, etc.
- Histograms
- Box plots
- Confidence intervals
- Monitor and detect adverse trends before a process goes out of control, using:
- Control charts: Shewhart, mean and range, cumulative sum control chart (CUSUM) and attribute charts
- Linear regression
- Assess the capability and reliability of a process
- Use and know the limitations of acceptance testing using ISO 2859
- Compare results using:
- T-tests
- Analysis of variance (ANOVA)
- Interpret the interaction of process parameters via experimental design and multivariate analysis
- Maintain regulatory compliance
Course Outline
Basic Statistical Quantities
- Terminology and definitions
- Measures and visual plots to describe populations and samples
- Deciding how much data to collect to enable appropriate decision making
Statistical Techniques
- Data visualization tools:
- Histograms
- Box plots
- Confidence and tolerance intervals
- Statistical process control (SPC) tools:
- Individuals, Shewhart, CUSUM and attribute control charts
- Pareto charts
- Fishbone diagrams
- Process capability (capability potential (Cp) and centered process capability (CpK)
- ISO 2859 specification for sampling procedures and tables, application of sampling by attributes
- Regression analysis
- Statistical testing:
- The t-test
- ANOVA
- Outlier testing
- Non-parametric methods
- Experimental design
- Multivariate analysis
Practical Application of Statistical Techniques
- Practical examples of the application of statistical techniques using teamwork sessions
- Experience of the application of statistical techniques in a quality assurance (QA) system in a manufacturing environment
- The role of computers in the application of statistical techniques
- Six Sigma: Definition and benefits
Who Should Attend
The Aspiring Qualified Person
- Our pharmaceutical mathematics and statistics training is generally considered 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 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 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. Taken with some of our other QP modules, this course is designed to lead to postgraduate certificate, diploma and MSc qualifications
Course Tutors
Course tutors will be selected from the following:
Peter Gough - Peter is an analytical chemist with over 40 years’ industry experience in applying statistical techniques to pharmaceutical manufacturing, testing and quality management.
David Young – David is a senior lecturer in the Department of Statistics and Modelling Science, University of Strathclyde who has carried out statistical consultancy work for the NHS, pharmaceutical companies and Health Protection Scotland.
Discounts
Multi-delegate discounts available. Discounts also offered to NHS staff and charities.
Qualified Person Training With NSF
Watch the video
Good Pharmacovigilance Practice
Cleaning Validation
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).
Pharmaceutical Microbiology
A highly interactive pharmaceutical microbiology training course, designed to provide you as an aspiring Qualified Person and pharmaceutical quality professional with the knowledge and understanding you need to: assess microbiological risks in the pharmaceutical manufacturing environment, assist in the design and implementation of comprehensive microbiological control strategies, and also so take informed decisions when microbiological problems occur.
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 and 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).