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The control of endotoxins in pharmaceutical products is imperative due to the varying level of immune responses incurred when introduced in to the blood stream.
Manufacturers of all parenteral drugs must ensure appropriate control, testing and removal methods are in place throughout the process to assure patient safety.
As the processes within quality control evolve, so do the endotoxin control methods and it essential to choose the right processes for your company to appropriately deal with the issue.

This workshop will give an overview of identifying an appropriate approach to address LER, calculating risk for contamination and a holistic approach to address the impurities.
 

Attendees of this workshop stand to gain:

1. Overview of best practices that participants can utilise in their daily work and laboratory operations
2. Understanding of crucial practices in the testing endotoxins
3. An insight into effective risk assessments for microbial impurities
4. Key considerations with LER

 

Workshop programme

13:30 Registration & Coffee

14:00 Workshop Leaders introduction

Friedrich von  Wintzingerode

Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech
View Bio

14:10 LER

Friedrich von  Wintzingerode

Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech
View Bio

  • Discussion of LER causing formulations and root causes
  • Conducting endotoxin hold time studies to detect  LER
  • Considerations for an effective Quality control strategy
  • 15:50 Tea Break

    16:20 CCAB: Interactive Session

    Friedrich von  Wintzingerode

    Friedrich von Wintzingerode, Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech
    View Bio

  • Interactive task: Calculating risks of microbial impurities in injectables – case study
  • A holistic approach to address the risk of microbial impurities on injectables
     
  • 17:10 Closing Discussion

    17:30 Closing remarks and end of workshop

    +

    FEATURED SPEAKERS

    Friedrich von  Wintzingerode

    Friedrich von Wintzingerode

    Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech

    Friedrich von Wintzingerode

    Senior Manager gASAT Microbiology, Global QC, Roche/ Genentech
    Friedrich von  Wintzingerode

    Friedrich is Senior Manager at Roche-Genentech Global Analytical Science and Technology, Global QC. He is Head of Roche-Genentech global Endotoxin Expert Group and Roche-Genentech global SME on microbial impurity contaminations and LER.
    After studying biology with focus on Microbiology at the Technical University of Braunschweig, Germany he earned his PhD at the Institute of Microbiology and Hygiene, Charité, Berlin, Germany.
     

    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    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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