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USP Microbiology 2022 – Keeping Up with Standards
April 29, 2022
USP Microbiology 2022 – Keeping Up with Standards

 

SAE Media Group’s 5th Annual Conference
Pharmaceutical Microbiology East Coast
April 27-28 2022 | Boston, US
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Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.


Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors are also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.

This workshop will be interactive while sharing the latest revisions and proposed revisions from the USP Microbiology Expert Committee. Some areas that will be discussed are sterilization, disinfectant efficacy testing, bacterial endotoxins test, B. cepacia test, microbial ‘sterility’ test for ATMPs, and microbiology best laboratory practices.
Bring your questions and learn how to use/interpret the USP microbiological information and standards with a member of the Expert Committee.

To register your interest or to get involved please contact: eshambler@SAE Media Group-online.co.uk

 

FEATURED SPEAKERS

Donald Singer

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, Ecolab
view all speakers

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, Ecolab
Donald Singer

Don Singer is Senior Microbiology Technical Consultant, N.A. for Ecolab, and a Fellow in the American Society for Quality. Don is currently Chair of the USP Microbiology Committee of Experts and has been a member of this committee since 2000. Don is a member of the European Pharmacopeia Group 1 Microbiology Committee. He is also chair of the PDA Task Force for the revision of Technical Report titled, “Pharmaceutical Package Integrity Testing”, and was co-author of the TR “Exclusion of Objectionable Microorganisms”. He is a Certified Specialist Microbiologist (NRCM) and Certified Pharmaceutical GMP Professional (ASQ), and a former Malcolm Baldrige National Quality Award Examiner. Don’s career spans over 40 years of research, quality control, quality assurance experience in the pharmaceutical, biopharmaceutical, personal care, cosmetic, and food industries. Currently Don is also an adjunct instructor in the Biopharmaceutical Quality graduate program at University of Maryland Baltimore County.

Workshop agenda

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14:00

Opening Remarks

Donald Singer
View Bio

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

clock

14:10

How Do I Best Use the USP?

Donald Singer
View Bio

Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • Monographs and General Notices
  • Benchmarking with General Information
  • Standards, Resource, Teaching Tool
    • clock

    14:40

    Latest Revisions in USP45 and Beyond

    Donald Singer
    View Bio

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • B. cepacia Test <60>
  • Microbial Tests for Sterile Short Shelf-Life Products <1071>
  • Sterilization topics <1229.16> <1229.17>
  • Guidelines on Bacterial Endotoxins Test <1085>
    • clock

    15:20

    Coffee Break

    clock

    15:50

    Latest Proposed Revisions in USP PF

    Donald Singer
    View Bio

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • Tests for ATMPs
  • Microbiology Best Laboratory Practices <1117>
  • Disinfectant Efficacy Testing <1072>
  • Validation of Alternatives for Bacterial Endotoxin Test <1085.1>
  • New Sterilization topics <1229.n>
    • clock

    16:30

    New Activities and Innovative Committee Thinking

    Donald Singer
    View Bio

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab

  • Controls for Cell and Gene Therapy Manufacturing
  • Containment and Contamination Control Monitoring
  • Alternative Microbiological Tests and Comparability
  • Will the Real Objectionable Microorganism Stand Up?
    • clock

    17:10

    Closing Remarks

    Donald Singer
    View Bio

    Donald Singer, Chair, General Chapters - Microbiology Expert Committee, Ecolab


    Donald Singer
    Donald Singer
    Chair, General Chapters - Microbiology Expert Committee
    Ecolab

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    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.
    HOTEL BOOKING FORM

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    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.

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    As a formal provider of CPD certified activities, SAE Media 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.

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