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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

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