Practical Implementation of Quality by Design
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Quality by Design (QbD) is a science and risk-based approach to product and process understanding
Monday 09 to Wednesday 11 July 2025
Manchester Marriott Victoria & Albert Hotel, Manchester, UK
£1575.00 excl. VAT – £1890.00 incl. VAT (first booking)
£1260.00 excl. VAT – £1512.00 incl. VAT (additional bookings from same site)
Type: Pharmaceutical
About this course
Quality by Design (QbD) is a science and risk-based approach to product and process understanding. Its application is changing the way the pharmaceutical industry develops and manufactures its products and the enhanced understanding that QbD provides will lead to business efficiencies.
Regulators are increasingly expecting to see the application of QbD and companies need, at the very least, to be aware of what QbD is but, more importantly, how it is applied and the implications it will have on the future way we develop, manufacture and control pharmaceutical products.
This course will provide the background to QbD and also its application using lectures and workshops presented by industry practitioners. It will also, via an invited speaker, give an insight into how one company has applied it in practice – participants will have the opportunity to interact with the presenter to find out more.
The fundamentals of QbD are covered in ICH guidelines Q8R (Pharmaceutical Development), Q9 (Quality Risk Management), Q10 (Pharmaceutical Quality System) and Draft Q11 (Development and Manufacture of Drug Substances). Q8, 9 and 10 guidelines were completed some years ago and Q11 is moving close to completion, so the focus is now on practical implementation of QbD and therefore will enable modernisation of industry and regulatory approaches.
QbD applied successfully delivers benefits for all stakeholders. This course will provide an understanding of why the ICH guidelines and the QbD approach are important and the benefits of implementation.
Whilst technically ICH guidelines provide guidance, they are accepted by regulators and ‘strongly recommended’. It is therefore essential that individuals and companies are fully aware of QbD and the potential competitive advantages of implementing its principles.
What You Will Learn
- Why the industry needs to change
- The intent of ICH Q8, 9 and 10 and how they fit together
- Fundamentals and practical uses of QbD
- Tools and techniques to support implementation
- Implementation case studies – real examples and business benefits from industry
Course outline
- The need for change
- Fundamentals of ICH Q8, 9, 10 and Draft 11
- How to implement QbD – the QbD roadmap
- Tools and techniques to aid implementation (risk assessment, PAT, DoE)
- Industry case studies and business benefits
- The reality of implementation
- Preparing for the future
Discussion and Working in 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
“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
An NSF International Company
