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In this workshop, the role of quality by design (QbD) in the development of a process will be discussed. An overview on QbD will be given from different perspectives (practical to regulatory), which practical references to the development of downstream operation and other types of pharmaceutical processes. This introduction will be followed to an introduction to Design of Experiments, with particular emphasis on design techniques and common pitfalls. The course will be integrated with notions on multivariate analysis (MVA), trying to answer common questions on what MVA is, and why should one use MVA in process development. Finally, additional modelling technologies to aid process development will be discussed, including the use of deterministic models, hybrid models and the extraction of process information using spectroscopic techniques.

This workshop is tailored for R&D people and for anyone willing to discuss about new technologies, in the frame of QbD and PAT initiatives, to speed up process development and make it more robust. References to current industrial initiatives (such as digitalization, big-data, machine learning and industry 4.0) will be discussed.

Previous attendees included:

 

Abzena; Albumedix; Almac Group; AmbioPharm; Bachem; Bachem Americas; Bachem Americas, Inc.; Bicycle Therapeutics; Bicycle Therapeutics Limited; BUCHI UK Ltd ; Chemi Spa; Complix NV; Cupid Peptide Company; Cupid Peptides ; Cyclogenix Ltd; DAISO Fine Chem GmbH; Haemostatix Ltd; Ipsen; Ipsen Research Laboratories; IRBM Science Park; Kition Research Limited; Ludwig Institute for Cancer Research; Marble Pharma Consult, sprl; MedImmune; Ministry Of Foreign Affairs; MorphoSys AG; MRC Technology; Pepticom LTD; Protagonist Therapeutics; Proxima Concepts Ltd; Sanofi-Aventis; Sanofi-Aventis Germany GmbH; Swedish Biomimetics 3000® Ltd; UCL School of Pharmacy; UCL/Astrazeneca; University Of Bristol; Zealand Pharma; Zealand Pharma A/S

Workshop LEADER

keynote-img

Alessandro Butte

Lecturer, ETH Zürich

Alessandro Butté received his Ph.D. in Chemical Engineering in 2000 from ETH Zurich. After a two-year post-doc at the Georgia Institute of Technology, he join the group of Prof. Morbidelli at ETH Zurich and completed his habilitation in 2008. During this period, his research activities focused on polymer engineering, production of nano-materials for protein purification (monoliths by reactive-gelation) and chromatography purifications of peptides, proteins and Mabs. In 2008, he joined Lonza as leader for downstream activities in the sectors small molecules and peptides and as project manager. He was also involved in the pilot program to introduce Quality by Design into R&D. In 2013, he joined back ETH as senior researcher. His current main research area is focused on the use of big data, advanced statistics and machine learning in combination with classical mechanistic models for risk management in R&D and manufacturing of biomolecules. He is author of more than 60 papers on international peer reviewed journals and several book chapters.

ETH Zürich

ETH Zurich (Swiss Federal Institute of Technology in Zurich) is a science, technology, engineering, mathematics and management university in the city of Zürich, Switzerland. The school was founded by the Swiss Federal Government in 1854 with the stated mission to educate engineers and scientists, serve as a national centre of excellence in science and technology and provide a hub for interaction between the scientific community and industry.
Twenty-one Nobel Prizes have been awarded to students or professors of the Institute in the past, allowing ETH Zurich to be consistently ranked among the top universities in the world. It is currently ranked as 5th best university in the world in engineering, science and technology.
The department of Chemistry and Applied Biosciences was one of the original 6 departments at ETH’s foundation and today counts 55 professors and more than 500 PhD students. The group of Prof. Morbidelli, whom Dr. Butté is member of, counts 4 senior researchers / lecturers, 7 post-docs and 21 PhD students in basic research and applied basic research.

Workshop programme

13:30 Registration & Coffee

14:00 Opening Remarks

14:10 Session 1 – Introduction to QbD

Alessandro Butte

Alessandro Butte, Lecturer, ETH Zürich
View Bio

A short overview on QbD and what it practically means in the everyday R&D life will be done.

14:50 Session 2 – Design of Experiments

Alessandro Butte

Alessandro Butte, Lecturer, ETH Zürich
View Bio

What is DoE and why DoE is useful in process development. Overview on DoE techniques, limitations and advanced designs. Discussion on how a wrong use of DoE could become counterproductive.

15:30 Afternoon Tea

16:00 Session 3 – Multivariate Analysis

Alessandro Butte

Alessandro Butte, Lecturer, ETH Zürich
View Bio

Introduction to multivariate analysis and the concept behind this. Overview of main MVA techniques, their objectives (clustering, regression, anomaly detection, etc.) and main differences with non-multivariate techniques.

 

16:40 Session 4 – Other advanced modelling techniques

Alessandro Butte

Alessandro Butte, Lecturer, ETH Zürich
View Bio

Introduction to other techniques, including deterministic models and hybrid models (combination of deterministic and machine learning). An overview of the statistical analysis of spectra coming from spectroscopic techniques will be also discussed and how spectroscopy can be integrated in process development (process understanding, trajectory analysis, control and prediction).

17:20 Closing Remarks

17:30 Close of Workshop

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VENUE

Holiday Inn Kensington Forum

97 Cromwell Road , London, United Kingdom

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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Holiday Inn Kensington Forum

97 Cromwell Road
London SW7 4DN
United Kingdom

Holiday Inn Kensington Forum

Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

HOTEL BOOKING FORM

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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