Module 01
Foundation · Free
DeltaV Overview
Introduces the role of a DeltaV-style DCS in biopharma manufacturing and everyday GMP operations.
- Learning outcome: Explain what the control system protects, how operators interact with it, and where CSV/CSA judgement begins.
- CSV/CSA relevance: Sets context for every validation boundary, test scope decision and review conversation that follows.
Module 02
Foundation · Free
System Architecture
Maps controllers, workstations, servers, historians and operator stations into a coherent architecture.
- Learning outcome: Identify physical and logical components that matter for validation scope, interfaces and evidence.
- CSV/CSA relevance: Architecture drives what you validate, how you partition risk and what auditors ask about segregation.
Module 03
Foundation · Free
Recipe · ISA-88
Explains ISA-88 recipe hierarchy — procedure, unit procedure, operation and phase — for batch consistency.
- Learning outcome: Navigate recipe structure and relate authored logic to executable batch behaviour.
- CSV/CSA relevance: Batch records, deviations, alarms and testing evidence all trace back to recipe design.
Module 04
Professional curriculum
Bioreactor Lab
Practical bioreactor-style control simulation for temperature, agitation and batch context.
- Learning outcome: Connect control behaviour to operator response and validation evidence expectations.
- CSV/CSA relevance: Builds intuition for process control reviews common in biopharma automation packages.
Module 05
Professional curriculum
Control Studio
Control Studio-style logic environment for loops, modes and configurable control strategies.
- Learning outcome: Read basic control logic structure and understand what changes require assessment.
- CSV/CSA relevance: Supports change control and regression testing conversations for configurable logic.
Module 06
Professional curriculum
DeltaV-Style HMI
Operator HMI interaction patterns for displays, commands and run-time visibility.
- Learning outcome: Interpret operator-facing graphics in the context of procedural control and alarms.
- CSV/CSA relevance: HMI design affects data integrity, alarm floods and human factors in batch execution.
Module 07
Professional curriculum
Alarm Triage
Alarm priority, shelving, acknowledgement and response discipline in a GMP context.
- Learning outcome: Distinguish actionable alarms from nuisance events and document proportionate responses.
- CSV/CSA relevance: Alarm management is a frequent audit and deviation topic in automated plants.
Module 08
Professional curriculum
Class-Based GEMs
Good engineering practice patterns for reusable module classes and configurable equipment.
- Learning outcome: Understand why class libraries matter for maintainability and validated state.
- CSV/CSA relevance: Supports CSA thinking about reusable software and controlled change.
Module 09
Professional curriculum
CSV Validation
Traditional CSV lifecycle thinking — requirements, testing and documented fit for intended use.
- Learning outcome: Map V-model stages to automation evidence without checklist-only compliance.
- CSV/CSA relevance: Core vocabulary for validation engineers and QA reviewers in regulated automation.
Module 10
Professional curriculum
V-Model
Verification and validation traceability across specification, build and test artefacts.
- Learning outcome: Link requirements to test evidence and spot traceability gaps reviewers would question.
- CSV/CSA relevance: Foundation for reading validation packages and scoping residual risk.
Module 11
Professional curriculum
CSA · Assurance
Computer Software Assurance — risk-based testing, critical thinking and proportionate evidence.
- Learning outcome: Apply assurance thinking to software features based on risk and intended use.
- CSV/CSA relevance: Increasingly central to FDA-aligned validation strategy for automated systems.
Module 12
Professional curriculum
CSV vs CSA
Compare traditional CSV and CSA approaches — when each lens applies and how they coexist.
- Learning outcome: Explain differences credibly to QA, IT and automation stakeholders.
- CSV/CSA relevance: Common interview and governance topic as organisations adopt CSA principles.
Module 13
Professional curriculum
Phase Logic · SFC
Sequential function chart thinking for phase logic, transitions and equipment coordination.
- Learning outcome: Read phase logic structure and identify where testing should focus.
- CSV/CSA relevance: Phase logic errors drive batch failures, deviations and revalidation effort.
Module 14
Professional curriculum
Change Control Lab
Assess automation changes for GxP impact, testing scope and approval discipline.
- Learning outcome: Complete impact assessment reasoning before approving configuration changes.
- CSV/CSA relevance: Change control is where validation and operations meet under audit scrutiny.
Module 15
Professional curriculum
Deviation Lab
Structured deviation handling — event description, evidence, root cause and CAPA thinking.
- Learning outcome: Work through a deviation narrative with proportionate investigation depth.
- CSV/CSA relevance: Deviation quality is a direct measure of GMP maturity in automated batch plants.
Module 16
Professional curriculum
Investigation Sandbox
Hypothesis-driven investigation with evidence notebooks and premature conclusion guards.
- Learning outcome: Build an investigation story supported by historian, audit and batch context.
- CSV/CSA relevance: Mirrors QA and validation lead expectations during event reviews.
Module 17
Professional curriculum
Audit Readiness
Inspector-style questions on alarms, trails, changes and batch evidence.
- Learning outcome: Answer audit prompts with defensible, evidence-backed responses.
- CSV/CSA relevance: Prepares practitioners for internal audits and regulatory inspection conversations.
Module 18
Professional curriculum
What If Engine
Explore consequence chains when configuration, logic or operator actions change.
- Learning outcome: Anticipate downstream GxP impact before approving changes or closing events.
- CSV/CSA relevance: Supports risk-based thinking required in CSA and mature change programmes.
Module 19
Professional curriculum
Knowledge Check
Cross-module knowledge check reinforcing CSV, CSA and automation vocabulary.
- Learning outcome: Identify gaps before capstone scenarios and professional curriculum completion.
- CSV/CSA relevance: Self-assessment for interview prep and learning-path confidence.
Module 20
Professional curriculum
Validation Digital Twin
Integrated validation capstone linking configuration, execution and evidence review.
- Learning outcome: Navigate a multi-stage validation story and launch the in-app Validation Digital Twin workspace.
- CSV/CSA relevance: Capstone bridge between modular learning and holistic package review.
Module 21
Professional curriculum
Batch Record Review
Guided batch record review connecting trends, alarms, phases and sign-offs.
- Learning outcome: Perform structured BRR thinking with explicit evidence citations.
- CSV/CSA relevance: Batch record review is a core QA and validation operations skill.
Module 22
Professional curriculum
Data Integrity Incident
Data integrity incident scenario — ALCOA+ thinking, audit trail review and escalation.
- Learning outcome: Assess data integrity risk and document investigation steps credibly.
- CSV/CSA relevance: Data integrity remains a top regulatory focus in electronic batch systems.