Home
overview

This workshop will start by covering the basics of freeze-drying cycle development, from the data required to start the R&D process to the data gained and decision-making that happen along the way. It will then provide more detail on different approaches including QbD, software-based cycle development, and the importance of understanding scale-up factors and strategies for reducing risk.

• Learn the fundamentals of lyo cycle development
• Understand the different approaches available to the R&D scientist
• Gain practical tips and advice from experienced practitioners
• Enjoy the informal interactive nature of the structured sessions!

Workshop programme

8:30 Registration & Coffee

9:00 Session 1: Approaches to cycle development

  • Classic iterative approach
  • Alternative approaches including automated systems
  • Pros and Cons of each approach
  • Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    9:30 Session 2: Classic iterative approach

    • What information is needed prior to cycle development?
    • Integrating formulation design with cycle development
    • How can we maximise data generation from each run?
    • Practical tips for planning cycles and analysing the outcome

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    10:30 Morning Coffee

    11:00 Session 3: Alternative approaches to cycle development

    • The use of software-based algorithms
    • Integrating QbD into the cycle development process

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    11:30 Session 4: Robustness testing and scale-up

    • Practical constraints of robustness testing
    • The use of DoE in robustness testing
    • Scale-Up factors, including differences in equipment, formulation and upstream processing parameters.

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, NIBSC

    12:20 Networking Lunch

    +

    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

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.