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Today more than ever regulatory guidance is increasingly focussing on the process robustness and product quality. The pharma world is also changing at an increasingly quickening pace. QbD philosophies must be quickly adapted for the development of any innovative products in order to ensure overall integrity.


QbD as a systematic approach enables products and process understanding and control, based on comprehensive science and quality risk management schemes. By understanding a product i.e. by formulation and processes in great detail, systematic approaches can be developed from an early stage to design quality into a product.
 

 

This year we will focus on how PAT plays a pivotal role in delivering the successful implementation of QbD validation. Practical case studies will be submitted associated with the potential pitfalls of practical applications, and how to avoid these hurdles. Practical approaches to QbD implementation in solid dosage forms and covering design as an end to end format.


2014 will see us focus on regulatory guidance from the FDA and MHRA and how we can deploy continuous process development - plant wide - into a previous operational plan.
 

  • Important regulatory agency feedback - A case by case study
  • Manufacturing a design space around your manufacturing QbD plan
  • Formulation processes - how QbD can be employed in your drug design process
  • Considerations in the future of PFS and how QbD can be incorporated

Refine and enhance a product's critical quality attributes
Develop a better manufacturing process design space
Employ QbD to design a formulation process
Harness raw material analysis and control strategy
Utilise PAT tools and applications for pharmaceuticals, biopharmaceuticals and ATMPs
Use risk assessment and management to best effect
Accurately include QbD information in regulatory document filings, including those for ICH Q8 and ASTM E 2500
Apply multivariate data analysis to maximise product development and patient outcomes
 

Active Pharmaceutical Ingredients
Advanced Analytical Sciences/Analytical Development
Vaccine Development and Production
Antibody Development and Production
Advanced Therapy Medicinal Products
Materials Science
Chemical Engineering
Chemistry, Manufacturing and Control
Research and Development
Tabletting
Process Analytical Technology
Laboratory Information Management Systems
Product Lifecycle Management
Good Manufacturing Practice
Formulation Science
Stability Testing
Lyophilisation
Good Distribution Practice
Supply Chain

AMRI; Arlenda; Baxter SA; Becton Dickinson Pharmaceutical System; Bristol Myers Squibb; Cambridge Crystallographic Data Centre; Esteve; Fujifilm Diosynth Biotechnologies; GSK; Health Protection Agency; Imperial College; Kyowa Hakko Kirin UK Ltd; Lonza Biologics; Loughborough University; MHRA; Mylan Pharma; National Institute For Biological Standards & Control; Newcastle University; Oxford BioMedica plc; Pall Corporation ; Purdue University; Sanofi Pasteur; Sindan Pharma srl; The Advanced Centre For Biochemical Engineering; UCB; UCL; UCL Biomedica; University Of Central Lancashire; University of Kent; University of Oxford Clinical BioManufacturing Facility; West Pharmaceutical Services;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Julian Morris

Julian Morris Technical Director Centre for Process Analytics and Control , Centre for Process Analytics & Control Technology

9:10 Successfully implementing quality by design: an introducttion to QbD & PAT

Peter Boogaard

Peter Boogaard Founder, Industrial Lab Automation

• Introduction to QbD concept and update on ICH Q10 and QbD Pharmaceutical Quality Systems guideline
• Overview of PAT technologies and industry examples in both development and manufacturing
• Introductory overview of Product Quality Lifecycle Implementation (PQLI) and Introduction to the 4 Product Quality System elements (PQS)
 

9:50 Application of QbD within a CMO

Simon  Hanslip

Simon Hanslip Senior Technical Project Leader, Process Design , Fujifilm Diosynth Biotechnologies

  • Benifits of adoption of QbD as a development paradigim
  • Application of QbD tools
  • Control strategy development
  • 10:30 Morning Coffee

    11:00 Application of QbD principles to formulation development of solids

    Frank Thielmann

    Frank Thielmann Operational Lead, Inhalation New Solids, Novartis Pharma AG

  • Design of experiments
  • Risk assessment
  • Multivariate analysis
  • Continous process verification
  • 11:40 Connecting the dots from clinical research to validation of processes and control strategy

    Pierre Lebrun

    Pierre Lebrun Associate Statistician - Project Leader, Arlenda

    • Connecting the dots from the factory floor to the patient outcomes
    • Presenting statistical software solutions to achieve effectively QbD in development
    • Numerous examples on processes, analytical procedures and bioassays
    • Effective implementation of Q8 applied from small molecules to vaccines
    • Understanding how to control risk from development to production

     

    12:20 Networking Lunch

    13:20 Enhancing process knowledge/understanding through the application of the Eyecon particle sizing PAT analyser

    Luke  Kiernan

    Luke Kiernan Technical Services Director , Innopharma Labs

    • Direct imaging particle size analysis - Eyecon
    • Use of the Eyecon to track process changes during fluid bed granulation processes
    • Development of a robust spheronisation process through understanding of the impact of particle size of the pellets
     

    14:00 Early screening of manufacturing to improve biotherapeutic design and selection

    Paul Dalby

    Paul Dalby Co-director of the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies, University College London

  • Advances in rapid screening and movelling for manufactureability
  • Untangling the relevance of rapid stability measurements to shelf-life prediction
  • 14:40 Meeting the regulatory expectations of quality by design

    Richard Dennett

    Richard Dennett Director Regulatory CMC, Voisin Consulting Life Sciences

    15:20 Afternoon Tea

    15:50 QbD at the interface of development to production

    Andreas Schreiner

    Andreas Schreiner Head Validation Manufacturing Science & Technology, Novartis

  • Development process - From small scale to production
  • Interface management
  • Case study
  • 16:30 Development of data management and analysis platform for continuous secondary processes

    Simeone Zomer

    Simeone Zomer Technical Manager, GlaxoSmithKline

  • Modelling opportunities of continuous vrs. Traditional batch processes
  • Modelling with sub-optimal and sparse datasets
  • Data management platforms to support advanced analytics
  • A perspective from design selection to control verification
  • 17:10 Panel Discussion: Analytical method developments

    Julian Morris

    Julian Morris Technical Director Centre for Process Analytics and Control , Centre for Process Analytics & Control Technology

    Simeone Zomer

    Simeone Zomer Technical Manager, GlaxoSmithKline

  • Strategies for chiral specific analytical methods
  • Assessing suitable phase choices for chiral specific methods
  • Common difficulties in this method
  • 17:50 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Julian Morris

    Julian Morris Technical Director Centre for Process Analytics and Control , Centre for Process Analytics & Control Technology

    9:10 QbD/PAT driven DP design and development

    Martin Schubert

    Martin Schubert Head of Chemical Pharma Development, UCB

  • Introduction: QbD/PAT concept for DP development
  • Case studies: Formulation development, Multivariate data analysis applied to historical data, PAT applications
  • Discussion
  • Conclusion
  • 9:50 Shifting tides in pharmaceutical manufacturing – Making continuous processing a reality

    Marcel de Matas

    Marcel de Matas Principal Scientist Formulation Science, AstraZeneca

  • The case for and barriers to the adoption of new technology in the pharmaceutical industry
  • The journey so far regarding implementation of continuous processing for solid oral dosage forms
  • Examples of where continuous manufacturing methods have been explored
  • 10:30 Morning Coffee

    11:00 Self-documenting processes to support ICH Q10 knowledge management

    Peter Boogaard

    Peter Boogaard Founder, Industrial Lab Automation

  • QbD paperless lab processes enables organisations to create start to finish knowledge management
  • Adopt cross functional collaboration between management, scientists and engineers
  • Paperless process is the ability to reduce variability significantly
  • Self-documenting processes that produces both non and GxP-complain docs
  • 11:40 Plant-wide control for integrated continuous pharmaceutical manufacturing

    Richard Lakerveld

    Richard Lakerveld Assistant Professor, Delft University Of Technology

    12:20 Networking Lunch

    13:20 Transforming data into knowledge to support PAT and QbD

    Julian Morris

    Julian Morris Technical Director Centre for Process Analytics and Control , Centre for Process Analytics & Control Technology

  • Variability challenges facing the implementation of PAT in R&D, QbD and production
  • How multivariate data analysis and modelling can lead to process and product know-how
  • How to use multivariate data analysis to provide enhanced production performance and optimise pharmaceutical processes
  • How PAT and data analytics can be more usefully used in early development and scale up
     
  • 14:00 Application of novel PAT and QbD principles to enhancing material and process understanding

    Mingzhong Li

    Mingzhong Li Principal Lecturer, De Montfort University

  • Using UV imaging and raman techniques to monitor APIs’ dissolution behaviour
  • Application of design of experiments for understanding a pulsed spray fluidised bed granulation process
  • Development of model based feedback control strategy for control of pulsed spray fluidised granulation
  • 14:40 Afternoon Tea

    15:10 The potential for imaging in the pharmceutical industry

    Michel Ulmschneider

    Michel Ulmschneider Scientific Specialist, Project Manager Spectroscopy and Chemometrics, F Hoffman - La Roche A G

  • 2D/3D chemical imaging
  • NIR, THz, etc
  • X-ray micro-CT
  • Solid state drugs
  • 15:50 Leverage QbD: Real time release testing

    Sachin Gahoi

    Sachin Gahoi Assistant General Manager, Mylan

  • How QbD enables real-time release testing
  • Unique considerations for implementing Real Time Release Testing
  • RTR testing Surrogates
  • Case Study
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andreas Schreiner

    Andreas Schreiner

    Head Validation Manufacturing Science & Technology, Novartis
    Marcel de Matas

    Marcel de Matas

    Principal Scientist Formulation Science, AstraZeneca
    Martin Schubert

    Martin Schubert

    Head of Chemical Pharma Development, UCB
    Michel Ulmschneider

    Michel Ulmschneider

    Scientific Specialist, Project Manager Spectroscopy and Chemometrics, F Hoffman - La Roche A G
    Simeone Zomer

    Simeone Zomer

    Technical Manager, GlaxoSmithKline

    Andreas Schreiner

    Head Validation Manufacturing Science & Technology, Novartis
    Andreas Schreiner

    Frank Thielmann

    Operational Lead, Inhalation New Solids, Novartis Pharma AG
    Frank Thielmann

    Julian Morris

    Technical Director Centre for Process Analytics and Control , Centre for Process Analytics & Control Technology
    Julian Morris

    Luke Kiernan

    Technical Services Director , Innopharma Labs
    Luke  Kiernan

    Marcel de Matas

    Principal Scientist Formulation Science, AstraZeneca
    Marcel de Matas

    Martin Schubert

    Head of Chemical Pharma Development, UCB
    Martin Schubert

    Michel Ulmschneider

    Scientific Specialist, Project Manager Spectroscopy and Chemometrics, F Hoffman - La Roche A G
    Michel Ulmschneider

    Mingzhong Li

    Principal Lecturer, De Montfort University
    Mingzhong Li

    Paul Dalby

    Co-director of the EPSRC Centre for Innovative Manufacturing in Emergent Macromolecular Therapies, University College London
    Paul Dalby

    Peter Boogaard

    Founder, Industrial Lab Automation
    Peter Boogaard

    Pierre Lebrun

    Associate Statistician - Project Leader, Arlenda
    Pierre Lebrun

    Richard Dennett

    Director Regulatory CMC, Voisin Consulting Life Sciences
    Richard Dennett

    Richard Lakerveld

    Assistant Professor, Delft University Of Technology
    Richard Lakerveld

    Sachin Gahoi

    Assistant General Manager, Mylan
    Sachin Gahoi

    Simeone Zomer

    Technical Manager, GlaxoSmithKline
    Simeone Zomer

    Simon Hanslip

    Senior Technical Project Leader, Process Design , Fujifilm Diosynth Biotechnologies
    Simon  Hanslip

    VENUE

    Marriott Regents Park

    128 King Henry's Road, London, United Kingdom

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    HOTEL BOOKING FORM

    Short interview with Dr Julian Morris, Technical Director, Centre for Process Analytics & Control Technology

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    Marriott Regents Park

    128 King Henry's Road
    London NW3 3ST
    United Kingdom

    Marriott Regents Park

    This 4 star north London hotel in zone 2 is the perfect destination for the astute business traveler as well as the leisure guest that knows how convenient north London hotels are, as a base from which to explore the city .Bond Street is just 3 stops from Swiss Cottage underground station on the Jubilee Line, so you can be shopping, exploring the sights and taking in one of London’s world-renowned West End shows in less than 15 minutes when you stay at this hotel near central London. At the same time, the hive of activity that is Camden Town, the chic shops, cafes and restaurants of Primrose Hill and ZSL’s London Zoo in Regents Park are all just a short walk from this hotel in north London.

    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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