QA / QC Learning Pathway

Quality in Biologic Manufacturing

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)
QA/QC Learning Pathway

Quality Assurance & Quality Control Analytics for Biologics Manufacturing

This training is designed for individuals seeking an understanding of how quality is ensured and controlled in biologics manufacturing. This learning pathway combines modules that build a foundational understanding of quality assurance principles, including quality systems, documentation practices, and compliance expectations. It also builds core competencies in quality operations and reinforces GMP-aligned thinking and decision-making. The pathway also provides a practical understanding of Quality Control workflows, testing methods, and the role of analytical and microbiological data in regulated manufacturing, including methods used for QC microbiological and QC analytical testing in biologics manufacturing.

3-day intensive Hands-on lab training 3 CASTL locations
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 Log in to the BioHubNet Training Platform, open the “Learning Pathways” tab, and request to enroll.
Travel & accommodation support Available for eligible participants travelling to a CASTL training site. Request travel support →
Assessment & instructor support Instructor-led assessment of practical skills, plus knowledge checks for the on-demand components.
01 — Pre-Requisites

Required preparation before the three-day workshop

Approximately 6–8 hours. Course access is provided after acceptance.

Regulatory

Introduction to GMP & QA/QC

Overview of Good Manufacturing Practice and the quality assurance and quality control functions governing biomanufacturing.

Lectures

Preparatory Lectures

Establish shared technical context and improve safety, readiness, and facility familiarity.

Analytics

Quality Control Analytics

Foundational concepts of QC analytics and the interpretation of analytical outputs in a quality context.

02 — Schedule

3-day training agenda

Day 1 — Quality within GMP & Contamination Control

  • Fundamentals of Quality within GMP
  • Contamination control
  • Environmental monitoring
  • Deviations, CAPAs, and risk mitigation
  • eQMS workflows and documentation discipline

Day 2-3 — Applied QC Foundations & Analytics

  • Introduction to QC and QC analytics
  • Documentation expectations and data integrity, including ALCOA+ principles
  • Applying risk-based thinking to QC outcomes and investigations
  • Integrating QC observations into deviation/CAPA thinking and quality decision pathways
03 — Learning Outcomes

What you will be able to do

Quality Systems

Quality Within GMP

Explain the fundamentals of Quality within a GMP environment and how quality systems operate in practice.

Contamination

Contamination Control

Apply contamination control concepts in quality decision-making contexts.

Monitoring

Environmental Monitoring

Demonstrate a foundational understanding of environmental monitoring purpose, signals, and response expectations.

Deviations

Deviations & CAPA

Document and communicate deviation scenarios in a structured, GMP-aligned manner, and apply structured thinking to CAPA development from cause to corrective and preventive action.

Risk

Risk Mitigation

Apply risk mitigation principles to quality events and operational decisions.

eQMS

eQMS & Documentation

Demonstrate baseline eQMS workflow familiarity and quality documentation discipline, applying ALCOA+-aligned behaviours during written and practical exercises.

QC Analytics

QC Analytics

Learn about analytical quality control testing in biopharmaceutical manufacturing, with a focus on product characterization, analytical instrumentation, data interpretation, and GMP-compliant practices used to support product quality and process consistency.

Microbiology

QC Microbiological Tests

Learn the fundamental principles and practical applications of microbiological quality control in biopharmaceutical manufacturing and how to monitor, investigate, and control microbial risks, supporting product quality and patient safety in biologics manufacturing.