Quality & Compliance Systems

QA/QC Management in Manufacturing Industry

Credits: 10 ECTS

Total Learning Effort: ~250 hours

Course Description

This certificate develops a system-level understanding of quality management and regulatory compliance in manufacturing. Participants study QA/QC frameworks, audits, data integrity, CAPA systems, and inspection readiness across regulated industries. The focus is on designing robust quality systems that ensure consistency, traceability, and compliance while supporting operational efficiency. Case-based learning highlights the organizational and system failures behind quality incidents. The program prepares leaders to move beyond reactive compliance and build proactive quality architectures that protect brand, customers, and long-term business performance.

Learning Outcomes (LOs)

Learners will be able to:

  • Design and manage integrated QA/QC systems
  • Interpret and implement global quality standards
  • Handle audits, deviations, CAPA, and investigations
  • Ensure data integrity and regulatory compliance
  • Embed quality culture across manufacturing operations

Module Structure (10 ECTS)

Module 1: Quality Fundamentals in Chemical Manufacturing (1.5 ECTS)

  • QA vs QC roles
  • Cost of poor quality
  • Quality maturity models
  • Customer-driven quality expectations

Module 2: Quality Standards & Regulations (2 ECTS)

  • ISO 9001, ISO 14001, ISO 45001
  • GMP, GLP relevance to chemicals
  • ICH, FDA, REACH, BRSR linkage
  • Global customer audit expectations

Module 3: Quality Control Systems & Lab Management (2 ECTS)

  • Analytical techniques overview
  • Method validation & calibration
  • Sampling, testing, release systems
  • OOS, OOT investigations

Module 4: Quality Assurance Systems (2 ECTS)

  • SOP management & documentation
  • Deviation handling & CAPA
  • Change management (MOC)
  • Risk-based quality management

Module 5: Audits, Inspections & Data Integrity (1.5 ECTS)

  • Internal & external audits
  • Regulatory inspections
  • ALCOA+ principles
  • Digital QA systems

Module 6: Quality Culture & Continuous Improvement (1 ECTS)

  • Human factors in quality failures
  • Lean Six Sigma in QA/QC
  • Quality KPIs & dashboards
  • Leadership role in quality

Assessment Strategy

  • Regulatory compliance quiz (15%)
  • Audit simulation exercise (25%)
  • CAPA & investigation assignment (30%)
  • Final project: QA/QC system design for a plant (30%)

Mapping

Standalone: PG Certificate in QA/QC Management

Stackable: PG Diploma / MBA

Career Roles: QA Manager, QC Head, Compliance Lead

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