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FLAGSHIP10 modules34 lessons~24 h
Pharma QC Microbiology Professional Program
Ten modules in the order a QC micro lab works, from GMP basics to facing audits, with a verifiable certificate.
What you'll be able to do
- ✓ Explain GMP, ALCOA+ and documentation the way auditors expect
- ✓ Prepare and qualify media with growth promotion testing
- ✓ Design and run environmental monitoring against Annex 1
- ✓ Perform MLT, sterility and BET with method suitability
- ✓ Investigate deviations, OOS and OOL results and write CAPA
- ✓ Answer QC microbiology interview questions with confidence
Syllabus
MODULE 1GMP foundations for the micro labSOPs, logbooks, documentation and data integrity.
- How this program worksFree preview
- GMP in the micro labFree preview
- Deviations, change control and CAPA in one picture
- Data integrity: ALCOA+ in practice
MODULE 2Media preparation and growth promotionFrom dehydrated media to released plates.
- Media types and their uses
- Preparing and sterilising media
- Growth promotion testing
- Culture maintenance and passage control
MODULE 3Environmental monitoring and cleanroomsGrades, methods, limits and excursions.
- Cleanroom grades and classification
- The four EM methods
- Alert and action levels, trending
- Handling an EM excursion
MODULE 4Pharmaceutical water systemsPW and WFI generation, monitoring and validation.
- Water grades and limits
- Generation and distribution
- Sampling and testing water
- Water system validation
MODULE 5Microbial limit testingTAMC, TYMC and specified organisms.
- USP <61>: TAMC and TYMC
- USP <62>: specified organisms
- Method suitability and neutralisation
MODULE 6Sterility testingUSP <71> from set-up to investigation.
- Membrane filtration and direct inoculation
- Method suitability for sterility
- Positive results and invalidation
MODULE 7Bacterial endotoxin testLAL methods, calculations and suitability.
- Endotoxins and the LAL reaction
- Endotoxin limit and MVD
- Gel clot vs kinetic methods
MODULE 8Validation in microbiologySterilisation, APS and disinfectants.
- Steam sterilisation and F₀
- Aseptic process simulation
- Disinfectant efficacy
MODULE 9Deviations, OOS/OOL and CAPAInvestigations that stand up to inspection.
- Phase I and Phase II investigations
- Root-cause tools
- Writing CAPA and effectiveness checks
MODULE 10Audits and career launchFace inspections and land the job.
- How inspections work
- Interview preparation and CV
- Final exam
Questions
Do I need lab experience?
No. The program starts from GMP basics and explains every test from first principles.
How long do I have access?
Lifetime access, including future updates to the lessons.
Is the certificate recognised?
It is issued by microbiologist.in and can be verified online by any employer using its code. It shows training, not a regulatory licence.
Can I study on my phone?
Yes, on the website or in the Android and iOS app.