Opening of the PDA Global Conference on Pharmaceutical Microbiology. Speaking is Dr. Mark Ott, Chief Microbiologist atNASA, on the topic of minimizing infectious disease risk while decreasing the necessary resources required during a spaceflight mission. Floating basketball-sized condensate harboring bacteria and fungi have been found on recent missions, making microbial monitoring extremely challenging!
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA