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
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



Donald Singer

Donald Singer

Chair, General Chapters - Microbiology Expert Committee, Ecolab

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



Opening Remarks

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



How Do I Best Use the USP?

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

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


    Latest Revisions in USP45 and Beyond

    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


    Coffee Break



    Latest Proposed Revisions in USP PF

    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


    New Activities and Innovative Committee Thinking

    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


    Closing Remarks

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

    Chair, General Chapters - Microbiology Expert Committee

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199

    Sheraton Boston Hotel

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    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.


    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.


    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, 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.


    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@saemediagroup.com

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