Rapid Microbiology
Module Lenght
half a day
Agenda
- History of microbiology methods
- International regulatory context overview
- Rapid Microbiology technology overview
- Growth Based
- Viability Based
- PCR based
- Validation Strategies
- Rapid Method Qualification
- IQ
- OQ
- PQ
Target audience
- Quality Assurance
- Quality Control
- Validation
- Manufacturing
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
Regulatory & technical references
- USP <1223> validation of alternative microbiological methods
- Eph 5.1.6 Alternative Methods for Control of Microbiological Quality
- GMP Annex 15
- PDA TR 33 Evaluation, Validation and. Implementation of New Microbiological Testing Methods
Number of trainers
One
Tailoring option available
No
Final evaluation quiz
Yes