QA / QC Learning Pathway

QC Microbiology

Entrepreneurship Bootcamp Timeline
Pre-training
Assessment, orientation,
access to preparatory material
and support (virtual)
In Lab Training
Hands-on laboratory work,
practical skills,
interactive case studies
(in person)
Post-training
Assessment and
Action Plan
(virtual)
Networking
Making new connections.
Follow-up
Program Impact
Survey
(virtual)
Total: 40h
QA/QC Learning Pathway

QC Microbiology for Biomanufacturing GMP-Simulated Setting

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.

3-day intensive Hands-on lab training Guelph, ON
Go to the BioHubNet Training Platform
To enroll
  1. 01 Apply for ENGAGE Training Credits on the BioHubNet Training Platform If you are not already enrolled in the BioHubNet ENGAGE program
  2. 02 Request to Enroll on the Training Platform under the Training Marketplace (under special programs)
Travel & accommodation support For participants travelling 2+ hours to the training site.
01 — Schedule

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)
02 — Learning Outcomes

What you will be able to do

Microbiology

Microbiology Fundamentals

Explain the basics of microbiology and identify common routes of contamination in the biomanufacturing environment.

GMP

GMP Requirements

Discuss GMP requirements and expectations in biomanufacturing and advanced therapy manufacturing contexts.

EM Program

Environmental Monitoring

Understand the types of monitoring in an Environmental Monitoring (EM) Program and design appropriate sampling plans.

Aseptic

Aseptic Gowning & Qualification

Understand aseptic gowning requirements and practice qualification testing procedures for cleanroom entry.

Release Testing

Product Release Testing

Learn about USP compendial tests for Sterility, Mycoplasma and Bioburden using Rapid Microbiological Methods (RMM).

CAPA

Deviations & CAPA

Respond to OOS/OOT deviations, perform root cause analysis, and implement corrective and preventive actions in a manufacturing setting.

03 — Pre-Requisites

Mandatory self-paced courses before arrival

(Course access provided upon acceptance.)

Safety

Lab Safety & Biosafety

Foundation safety principles for laboratory and biological environments — mandatory before in-person training begins.

Regulatory

Introduction to GMP & Regulatory

Overview of Good Manufacturing Practice requirements and the regulatory framework governing biomanufacturing.

Documentation

Fundamentals of GDP

Core principles of Good Documentation Practice including data integrity, batch records, and ALCOA+ standards.

Monitoring

Environmental Monitoring

Introduction to environmental monitoring programs, sampling methodologies, and alert and action limits in cleanroom settings.

Risk

Risk Assessments & Deviations

Foundational concepts in risk assessment methodologies and deviation management in a GMP-regulated environment.

CAPA

CAPA

Introduction to Corrective and Preventive Action frameworks and their role in continuous quality improvement.