Practical Implementation of Quality by Design: Statistical Techniques for Product Development
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This course will provide you with an introduction to the power and practical application of these multi-variate tools and techniques.
Thursday 12 to Friday 13 July 2025
Manchester Marriott Victoria & Albert Hotel, Manchester, UK
£1360.00 excl. VAT – £1632.00 incl. VAT (first booking)
£1088.00 excl. VAT – £1306.00 incl. VAT (additional bookings from same site)
Type: Pharmaceutical
About this course
The science and risk-based approach to the development of pharmaceutical products and processes, which is generally referred to as Quality by Design (QbD), requires the application of multi-variate statistical tools.
The ‘traditional’ empirical approach to the development of products, which changes one variable at a time, suffers from the fundamental weakness that often variables are not independent. In order to explore the interactions between variables a multi-variate approach is needed.
Multi-variate statistical tools, such as Design of Experiments (DoE), Principle Component Analysis (PCA), Partial Least Squares (PLS), etc. have been utilised by other industries for decades. Modern computer software makes performing these analyses simpler than they have ever been in the past.
This course will provide you with an introduction to the power and practical application of these multi-variate tools and techniques.
What You Will Learn
- How to recognise the potential of DoE in product and process development
- How to apply DoE for identifying Critical Process Parameters (CPPs), material attributes and interactions as well as understanding the impact of variability on Critical Quality Attributes (CQAs)
- How to appreciate the role of experimentation and to select the correct experimental design for the intended purpose
- To understand how DoE can be used to help develop a design space
- How models based on DoE can be used as surrogates for traditional testing of CQAs
- How to use basic statistics for development activities
- How multi-variate data analysis can be used to gain process understanding from a large dataset, e.g. arising from PAT application
- How to take advantage of increased batch control using large sample sizes
Course outline
- The application of statistics, DoE and multi-variate data analysis within pharmaceutical development to developing process understanding
- DoE basics
- Practical DoE exercises
- Basic statistics, including process capability, SPS, control charts
- Multi-variate data analysis and how it is used in relation to development activities, including PAT
- Sampling and analysis of large datasets
Discussions and Working Groups
A significant proportion of course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, including a course tutor panel session, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
Manchester Marriott Victoria & Albert Hotel, Manchester, UK
The Manchester Marriott Victoria & Albert Hotel stands on the banks
of the River Irwell, near the city centre but convenient for Manchester
Airport (19km), the city’s Piccadilly rail station (3km) and the UK’s motorway networks.
Recently lovingly restored, this Grade II listed building bears many modern features. The hotel has its own car park and the Living Well Health Club with pool, gymnasium, sauna and steam room is just a few
minutes from the hotel.
Also nearby are the Imperial War Museum North West, Lowry Museum and Manchester’s three theatres. A few minutes’ walk takes you to the city’s main shopping and eating district.
Hotel Accommodation
- We have a block booking of bedrooms at the Manchester
Marriott Victoria & Albert, at a specially negotiated bed and breakfast rate per delegate per night.
- As part of our improvements to the booking process, we have arranged for an online booking service with the hotel and details of how to make your accommodation booking will be included in your course joining instructions
(issued to you at the time of booking). Alternatively you will be able to make a telephone booking directly with the hotel. If you need any help or guidance with the accommodation booking process, please contact our course administration team.
- Your account with the hotel should be settled at check out.
- Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain
your responsibility, therefore please ensure you are aware of the hotel’s cancellation policy.
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our experts for this course are:
What you've said
What previous delegates said about part 1
“This course gave me a large view and good understanding of QbD. I’ll try to apply it to new products in my company.”
Celine Anselmetti, Debiopharm Group, Switzerland
“Very comprehensive course with inspiring examples!”
Celine Mahe, Celgene International, Switzerland
“Very good use of case studies to clearly demonstrate application. Clear and uncomplex delivery by tutors which resulted in clear understanding to deliver back to the company.”
Howard Thomas, BTG International Ltd (Protherics UK), UK
“Excellent course; very practical.”
Hilde Lievens, Baxter, Belgium
“Very interesting course with excellent tutors. I will definitely take back the methodologies to the work place.”
Clare Watson, MedImmune UK, UK
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