QC Microbiology for Biomanufacturing
This training is designed for individuals seeking an understanding of the microbiological risks in the biomanufacturing environment and the tools used to monitor and mitigate them, as well as the theory and practical skills needed for microbiological release testing. No prior microbiology experience required.
- 01 Apply for ENGAGE Training Credits on the BioHubNet Training Platform If you are not already enrolled in the BioHubNet ENGAGE program
- 02 Request to Enroll on the Training Platform under the Training Marketplace (under special programs)
3-day training agenda
Day 1 – Sterility Assurance & Environmental Monitoring
- Microbiology basics and contamination routes
- Sterility assurance of cleanrooms
- Environmental monitoring principles
- Aseptic gowning and qualification testing
Day 2 – Microbiological Release Testing
- Sterility and Mycoplasma testing
- Rapid Microbiological Methods (RMM)
- Fundamental Lab skills
Day 3 – Root Cause Analysis & CAPA
- Sterility testing
- Industry case studies
- OOS/OOT deviation response
- Root cause analysis methods
- Corrective and preventive action (CAPA)
What you will be able to do
Microbiology Fundamentals
Explain the basics of microbiology and identify common routes of contamination in the biomanufacturing environment.
GMP Requirements
Understand the GMP requirements that govern biomanufacturing, including documentation, cleanroom controls, and quality systems.
Environmental Monitoring
Understand the types of monitoring in an Environmental Monitoring (EM) Program and design appropriate sampling plans.
Aseptic Gowning & Qualification
Understand aseptic gowning requirements and practice qualification testing procedures for cleanroom entry.
Product Release Testing
Learn about USP compendial tests for Sterility, Mycoplasma and Bioburden using Rapid Microbiological Methods (RMM).
Deviations & CAPA
Respond to OOS/OOT deviations, perform root cause analysis, and implement corrective and preventive actions in a manufacturing setting.
Mandatory self-paced courses before arrival
(Course access provided upon acceptance.)
Lab Safety & Biosafety
Foundation safety principles for laboratory and biological environments – mandatory before in-person training begins.
Introduction to GMP & Regulatory
Overview of Good Manufacturing Practice requirements and the regulatory framework governing biomanufacturing.
Fundamentals of GDP
Core principles of Good Documentation Practice including data integrity, batch records, and ALCOA+ standards.
Environmental Monitoring
Introduction to environmental monitoring programs, sampling methodologies, and alert and action limits in cleanroom settings.
Risk Assessments & Deviations
Foundational concepts in risk assessment methodologies and deviation management in a GMP-regulated environment.
CAPA
Introduction to Corrective and Preventive Action frameworks and their role in continuous quality improvement.
Enroll in QC Microbiology Training
Apply for training credits and secure your spot on the BioHubNet Training Platform.