EDGE: Certified Training
Program for Microbiologists
Course Description
Today’s manufacturing is governed by increased process & equipment complexity, fast changing technology, greater importance of regulatory compliance & technical production transfers. This means staying abreast of the latest industry advancements is vital for the development and success of a company and its employees. Our state-of-the-art courses are designed to help manufacturers meet critical needs for process efficiency and cGMP compliance.
Who should attend?
- Users from Microbiological QC & QA departments
- Microbiology personnel from testing laboratory
- Microbiology professionals aspiring career in industrial microbiology
What will you receive?
- A copy of the course materials
- A certificate of attendance
Registration Fees
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Registration Fees: 15.000/- Indian Rupeen Plus Taxes
Fees include training material, refreshments and lunch during the course period. Travel & Logistics to be borne by the participants.
Enrollment is Limited
We recommend early booking to ensure a place.
Course Schedule and Program
Day 1
- Back to basic – Refresher session on basics of microbiology
- Significance of Water for Microbiology Applications
- What’s Bugging you about BioBurden Testing
- Validation of Alternate Microbiological Methods
- Culture Media Preparation, Performance Testing & Trouble Shooting
as per USP <1117> & ISO 11133
Day 2
- Environment Monitoring in Classified Areas
- ISO 14698 & ISO 14644
- Process Simulation - Media Fill Test
- Hands-On Session on BioBurden and Environmental Monitoring
Day 3
- Sterility testing in Pharmaceutical Industry (Reference USP chapter <71>)
- Pyrogen testing using monocyte cell lines (reference EP chapter <2.6.30>)
- Microbial Contamination Testing and Validation / 483 USFDA and Audit Handling
- Hands-on session on sterility testing