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This workshop will provide the fundamental knowledge on the latest technological and regulatory developments regarding the analysis of endotoxin in pharmaceutical products and pharma production environments. Furthermore the underlying mechanisms of Endotoxin Masking (Low Endotoxin Recovery, LER) in pharmaceutical formulations will be explained as well as the newly developed sample preparation methods.

• Quality Control and Production professionals from pharmaceutical and biotech industries
• R&D pharma and biotech, especially new drug formulation development
• Research Institutes and Universities

Workshop LEADER

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Karolina Heed

Director Marketing & Sales, Hyglos GmbH

Karolina Heed studied chemistry and economics in Gothenburg Sweden and Florence Italy. Prior to heading the marketing & sales of Hyglos GmbH, Ms. Heed worked almost 10 years in the biotech industry in different roles.
 

Hyglos GmbH

Hyglos GmbH is a leading biotech company offering highly innovative technology for removal and detection of Endotoxins, located in Biotechnology Center Bernried, Munich area, Germany. Being an IAFP Safety Innovation Awardee we apply our proprietary technology for developing highly specific bacteriophage-derived proteins for improved detection and removal of harmful bacteria and bacterial toxins such as Lipopolysaccharides (LPS). Hyglos was founded in 2009 and fulfils all development and production requirements according to ISO 9001 and 13485.

Workshop programme

12:20 Refreshments

13:30 The Recombinant Factor C (rFC) Test - New method in the European Pharmacopoeia

Karolina Heed

Karolina Heed, Director Marketing & Sales, Hyglos GmbH
View Bio

  • Introduction BET and Pyrogen Test Methods
  • New Ph. Eur. chapter 5.1.10
  • 14:10 Implementation of the rFC test in a routine service laboratory

    Karolina Heed

    Karolina Heed, Director Marketing & Sales, Hyglos GmbH
    View Bio

  • Endotoxin testing under GMP
  • Bioanalytical Method Validation of the rFC test
  • 14:50 Afternoon Tea

    15:20 Endotoxin Detection of Biologics I - What are Masking Effects?

    Holger Grallert

    Holger Grallert, Head of R&D, Hyglos GmbH

  • Endotoxin structure and activity
  • Impact on detection systems
  • Masking of endotoxin (LER)

     

  • 16:00 Endotoxin Detection of Biologics II - Demasking Endotoxin with dedicated sample preparation

    Holger Grallert

    Holger Grallert, Head of R&D, Hyglos GmbH

  • Demasking protocol development
  • Implementation of demasking method - case studies
  • Regulatory requirements
  • 16:40 Chairman’s Closing Remarks and Close

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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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