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This workshop will introduce ideas for blending traditional microbiology with the cutting edge methodologies that are available to the industry, both inside the laboratory and on the manufacturing floor for routine monitoring programs. It will also provide practical approaches for common laboratory issues surrounding implementation of alternative technologies, data integrity and analyst training.

 

Co-hosted by:

Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)

Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)

This workshop is designed to inspire and motivate the attendee for understanding the evolution of microbiological methods in pharmaceutical manufacturing, and basic expectations for building quality into the product.

Previous conference attendees included:

 

Abbott Biologicals; Abbott Biologicals B V; Abbott Biologicals B.V; Astrazeneca; Atheris Laboratories; BD Life Sciences; BPL; Clean Air and Containment Review; Confarma France S A R L; Debiopharm Research & manufacturing SA; Dyson Technology Ltd; GE Healthcare; GSK; GSK Manufacturing S.p.A.; GW Pharmaceuticals; Hyglos GmbH; iDev; IDEXX Technologies Limited; Innaxon; International Confederation of Contamination Control Societies ; London Research Institute; Lonza Biologics Plc; Lonza Incorporated; Martindale Pharmaceuticals; MedImmune; Merck; Merck Chemicals Ltd; Merial; Merial Sas; Merial Saude Animal Ltda; Mettler-Toledo Ltd; MSD Animal Health; Nestle Research Center; Nova Laboratories; Novartis Vaccines; Oxford BioMedica; Pharmig; PHSS; Public Health England; Queen’s University, Kingston, Ontario; Sanofi Pharma; Sanofi-Aventis; Sigma Aldrich; STERIS Corporation; Teva UK Ltd; Trafalgar Scientific Ltd.; University of Southampton; Vetter Pharma-Fertigung GmbH & Co. KG; Wickham Laboratories Ltd

Workshop LEADER

keynote-img

Vanessa Vasadi-Figueroa

Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)

Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 12 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Mrs. Figueroa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Mrs. Figueroa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz, and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and contributing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

Quality Executive Partners (QxP)

At Quality Executive Partners (QxP), our mission is to bring bold revolution to quality consulting. We are fueled by the passion for doing what is right and being the much needed disruptive innovation! The QxP team is comprised of executives with extensive track records delivering successful outcomes in situations of intense regulatory scrutiny. Our executives have substantial experience interacting and negotiating with FDA and other global regulatory agencies. We take a pragmatic, strategic view of internal processes, quality system development, and implementation of key matters.

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks

9:10 Session 1 - The Modern Microbiology Lab

  • Learn about current trends in QC Microbiology
  • Solutions for when to upgrade technology in your lab

  •  

     

    Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)
    View Bio

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)
    View Bio

    9:50 Session 2 - Real Time Release Testing

  • Learn about options available for monitoring water & products in real time
  • Discuss the creation and application of new excursion criteria
  •  

     

    Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)
    View Bio

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)
    View Bio

    10:30 Morning Coffee

    11:00 Session 3 - Data Integrity in a Digital Lab

  • Application of Data integrity for conventional & alternative lab methods
  • Practical approaches & safeguards against common mistakes
  •  

     

    Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)
    View Bio

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)
    View Bio

    11:40 Session 4 - The iMicrobiologist

  • Blending old & new technologies in the QC Microbiology lab
  • Understanding, hiring & training the new generation of talent

     

     

  • Vanessa Vasadi-Figueroa

    Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist, Quality Executive Partners (QxP)
    View Bio

    Robert Ferer

    Robert Ferer, Consulting Partner / Strategic Practice Lead, Quality Executive Partners (QxP)
    View Bio

    12:20 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.

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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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