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Myths Associated with Objectionable Organisms

Profound root cause analysis and continuous improvement to control bioburden on a particular process step during manufacturing of biologic products

T.C. Soli, Soli Pharma Solutions

Microbiologic Qualification in Isolators using H2O2 – « Bugs don’t lie »

Perspectives on use of Plant Isolates in Pharma Microbiology

Rapid Automated Inspection of Sterile Media Fills

Microbial Contamination of Non-Sterile Dosage Forms

Implementation of Rapid Microbiological Methods: Microbiological Mycoplasma Assay with PCR

Implementation of Rapid Microbiological Methods : ATP Bioluminescence

Solutions for Addressing Bacterial and Fungal Spore Contamination

How Real are the Microbiological Results Presented in the Microbiological Laboratory During a Manufacturer Inspection?

Implementation of Requirements for Environmental Monitoring from Different Regulatory Authorities

Reliability of Endotoxin-Detection: Mechanistical Principals of Endotoxin- masking and Strategies for Demasking

Endotoxin Aggregation & Binding Properties... Recovering endotoxin spikes from products & container-closures

List of Attendees

Inspection Observations: Experiences from Inspections of Companies/Facilities

An Exploration Into the Value of Obtaining Microbiological Data Rapidly

Challenges in Validating Microbiological Methods with a Radio-Pharmaceutical

USP <1115> ‘Bioburden Control of Nonsterile Drug Substances and Products.’ - A Review of the Draft Chapter and Case Study

Case Study: A Multi-Faceted Approach for Thorough Root Cause Analysis in Microbial Investigations

Conducting an Endotoxin Sample Storage Study Relevant for Manufacturing of a Biologic Product

House Flora, Isolates and Disinfection Coupon Testing: An Integrated Approach

On the Update of EP 5.1.6: Alternative Methods for Control of Microbiological Quality

Microbial Risk Assessments for Operational Cleanrooms