Principles of engineering applied to the pharmaceutical industry

Unit operations in pharmaceutical processes (e.g., mixing, granulation, drying, filtration, crystallization)

Extraction and purification processes (distillation, chromatography, ultrafiltration)

Processes for the production of sterile APIs (including HPAPIs) and sterile finished medicinal products

Bioreactors and advanced technologies for biological and biosimilar medicinal products

Production of vaccines and cell therapies in controlled environments

Single-Use Systems (SUS) for pharmaceutical manufacturing

Introduction to microbiology

Annex 1: EU GMP Guidelines for the Manufacture of Sterile Medicinal Products

Aseptic techniques and prevention of microbiological contamination

Classification and management of cleanrooms (ISO 14644-1)

HVAC systems for sterile environments

Sterilization and biodecontamination techniques: filtration, autoclaving, VHP (Vaporized Hydrogen Peroxide)

Validation and qualification strategies for aseptic facilities (Media Fill Test, Smoke Studies)

Use of Isolators and RABS (Restricted Access Barrier Systems)

Levels of design (concept, basic, detailed), regulatory references, and current trends (ISPE and others)

Principles of pharmaceutical facility design and layout (including HPAPI and biological agents, BLS1–4)

Space management and optimization (differential pressure zones, laminar airflows, HVAC systems)

Water treatment plants for pharmaceutical use (WFI – Water for Injection, Purified Water, Pure Steam)

Continuous Manufacturing vs. Batch Manufacturing

Sizing, energy management, and sustainability in pharmaceutical plants

Project management

Strategies for commissioning and the FAT/SAT phases (Factory Acceptance Test, Site Acceptance Test)

Testing methods for sterility and microbiological contamination control

Environmental sampling and microbiological monitoring techniques

Endotoxin and particulate testing in sterile products

Decontamination and validation strategies for isolators

Validation of terminal sterilization and aseptic filling processes

Validation and qualification of equipment and processes (IQ, OQ, PQ)

Real-time monitoring and Process Analytical Technology (PAT)

Risk analysis and safety engineering in pharmaceutical processes

Management of chemical (HPAPI) and microbiological (viral) contamination

Industry 4.0 (and 5.0) and the digital transformation of pharmaceutical manufacturing

Automation and robotics for the handling of sterile products

SCADA and MES (Manufacturing Execution Systems) for process control

Machine Learning and Artificial Intelligence for process optimization

Data integrity and electronic document management (21 CFR Part 11 compliance)

Traceability and serialization in pharmaceutical logistics

Optimization of the pharmaceutical supply chain and production flow