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Quality by Design (QbD) is an approach that has been implemented in many manufacturing settings and across a broad range of industrial sectors. Its application is ever widening to cover a large number of processes that may previously have been considered to be outside its remit or grasp. In recent years, the application of the QbD approach to freeze-drying has been the subject of a small number of published studies, although there is arguably a long way to go before Best Practice can be agreed and opinions harmonized.

 

This half-day Workshop on QbD in Lyophilization will cover a number of aspects of the QbD approach and how it might be successfully applied to the freeze-drying process, as well as upstream activities (formulation, filling, loading) and postdrying issues.
 

Topics to be covered include:

  • Can the QbD appraoch be applied to formualtion and cycle development as an integrated process?
  • How can the different risks arising within the freezing and drying stages of the process be assessed/accommodated?
  • Is it possible to find a good balance of desktop studies and practical freeze-drying that won't be unnecessarily onerous?
  • What level of detail should we go in to assessing the risk and generating supporting data?

Delivered as a combination of short presentations on QbD concepts and case studies, interspersed with discussion sessions and small groupwork exercises, the Workshop is designed to be an interactive session where participants are also invited to share their views and experiences with fellow attendees to gain maximum value from the session.

Workshop programme

8:30 Registration & Coffee

9:00 Welcome and Opening Remarks

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

9:10 Basic Principles of QbD and what it means for lyophilization

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

9:30 Defining Critical Quality Attributes and a Target Product Profile for a lyophilized product

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

10:00 Risk minimization and "Risk Dynamics" in Freeze-Drying

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

10:30 Morning Coffee

11:00 Building a Design Space:

Kevin Ward

Kevin Ward, Director of R&D , BioPharma Technology

  • The interplay between equipment, formulation and process
  • Integration of formulation and process design/development
  • Looking at the balance between desktop studies and lab trials
  • 12:00 Final interactive discussion session and summing up

    Kevin Ward

    Kevin Ward, Director of R&D , BioPharma Technology

    12:30 End of Workshop

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    FEATURED SPEAKERS

    Kevin Ward

    Kevin Ward

    Director of R&D , BioPharma Technology

    Kevin Ward

    Director of R&D , BioPharma Technology
    Kevin Ward

    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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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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