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Attendee Presentations

2014 PDA Conference on Pharmaceutical Microbiology

  • Anil Sawant
    Myths Associated with Objectionable Organisms
  • Babs Van de Plas
    Profound root cause analysis and continuous improvement to control bioburden on a particular process step during manufacturing of biologic products
  • BONUS - Common Pharmaceutical Water System Inspection Pitfalls
    T.C. Soli, Soli Pharma Solutions
  • Christian Doriath
    Microbiologic Qualification in Isolators using H2O2 – « Bugs don’t lie »
  • David Myatt
    Perspectives on use of Plant Isolates in Pharma Microbiology
  • Derek Duncan
    Rapid Automated Inspection of Sterile Media Fills
  • Di Morris
    Microbial Contamination of Non-Sterile Dosage Forms
  • Esther Presente
    Implementation of Rapid Microbiological Methods: Microbiological Mycoplasma Assay with PCR
  • Inge Van der Schoot
    Implementation of Rapid Microbiological Methods : ATP Bioluminescence
  • James Polarine
    Solutions for Addressing Bacterial and Fungal Spore Contamination
  • Jean Denis Mallet
    How Real are the Microbiological Results Presented in the Microbiological Laboratory During a Manufacturer Inspection?
  • Jette Christensen
    Implementation of Requirements for Environmental Monitoring from Different Regulatory Authorities
  • Johannes Reich
    Reliability of Endotoxin-Detection: Mechanistical Principals of Endotoxin- masking and Strategies for Demasking
  • Kevin L. Williams
    Endotoxin Aggregation & Binding Properties... Recovering endotoxin spikes from products & container-closures
  • List of Attendees
    List of Attendees
  • Manuel Ibarra
    Inspection Observations: Experiences from Inspections of Companies/Facilities
  • Nigel Halls
    An Exploration Into the Value of Obtaining Microbiological Data Rapidly
  • Nina Dorre
    Challenges in Validating Microbiological Methods with a Radio-Pharmaceutical
  • Paul Newby
    USP <1115> ‘Bioburden Control of Nonsterile Drug Substances and Products.’ - A Review of the Draft Chapter and Case Study
  • Rebecca Clark
    Case Study: A Multi-Faceted Approach for Thorough Root Cause Analysis in Microbial Investigations
  • Ruth Daniels
    Conducting an Endotoxin Sample Storage Study Relevant for Manufacturing of a Biologic Product
  • Samuel Saxer
    House Flora, Isolates and Disinfection Coupon Testing: An Integrated Approach
  • Stephen Wicks
    On the Update of EP 5.1.6: Alternative Methods for Control of Microbiological Quality
  • Tim Eaton
    Microbial Risk Assessments for Operational Cleanrooms