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SMi proudly presents the half-day workshop on Lyophilization - Implementation of Quality by Design principles into Lyophilization processes at Lyophilization USA 2017!

Short introduction into QbD in the context of Lyophilization processes quality target product profi le for freeze-dried
products. Critical quality attributes for freeze dried products. What is relevant for the lyoprocess? The Critical Formulation
Temperature- how to determine the CFT – what is the relevance of the Critical Formulation Temperature. The use of
PAT to monitor critical performance attributes of process and product Lyocycle robustness testings

  • Learn about quality built into the process in the context of lyo
  • Understand the interrelationship of formulation and process
  • Learn how to determine the CFT
  • What PAT techniques are available?
  • Lyocycle robustness testings to evaluate the process
  • boundaries, how to transfer this into commercial scale lyophilization

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:

  • Freeze-drying/ Lyophilization
  • Formulation Scientist
  • Bioprocessing
  • Process Development
  • Sterile/ Fill-Finish
  • Production
  • PAT
  • CMC
  • Chemistry
  • Manufacturing
  • Quality Assurance
  •  

Workshop LEADER

keynote-img

Andrea Weiland-Waibel

Managing Director, Explicat Pharma GmbH

Andrea Weiland, Ph.D., is Managing Director of Explicat® Pharma GmbH, a privately owned
company providing technical project management services and pharmaceutical development services to Pharmaceutical Industry (CMC). she is a Pharmacist with a Ph.D in Pharmaceutical Technology on biodegradable microspheres and cyclodextrins (Ludwig Maximilians University Munich). She held several leadership positions within Pfizer, working as Project Manager in process technology and being responsible for technology transfer & process development, mainly on sustained release solid dosage forms. Within R&D she was Responsible Scientist for pharmaceutical development
(Phase I - III, candidate characterization and Lyophilization projects. Andrea Weiland is Qualified Person and a member of AAPS as well as several other professional institutions based in Europe, e.g. APV, DphG, Bay. LAK, A3P.

Explicat Pharma GmbH

Explicat was founded by Dr Andrea Weiland, Birgit Hettinger and Ulrich Waibel in 2005. Since then, Explicat supports
pharmaceutical companies, manufacturers, developers and laboratories around the world. Explicat comprises the know how of pharmacists, engineers, chemists, biochemists and economists with international experiences.

Workshop programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 Session 1 - Short Introduction into QbD in the context of Lyophilization processes

Andrea  Weiland-Waibel

Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
View Bio

  • What is QbD?
  • QbD and the Lyoprocess
  • Quality target product profi le for freeze-dried products
  • Critical Quality attributes
  • 9:50 Session 2 - The Critical Formulation Temperature

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
    View Bio

  • How to determine the CFT
  • The CFT determined by predominantly amorphous or crystalline systems
  • Tg’ and Te
  • Controlled Nucleation/Annealing
  • 10:30 Morning Coffee

    11:00 Session 3 - PAT Tools available for Lyophilization Processes

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
    View Bio

  • MTM - batch method
  • TDLAS
  • Comparative pressure measurement
  • Invasive Thermocouples and TEMPRIS
  • 11:40 Session 4 - Lyocycle robustness testings to evaluate the process boundaries and how to transfer this into commercial scale lyophilization

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH
    View Bio

  • Lyo robustness testings and their regulatory relevance
  • Establish process boundaries
  • Transfer in commercial scale
  • How to include the work into the regulatory submission
  • 12:20 Chairman’s Closing Remarks

    12:30 Close of workshop

    +

    VENUE

    Renaissance Woodbridge Hotel

    515 US Highway 1 South, Iselin, New Jersey, USA

    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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    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.

    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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