Drug Production Systems

What You Will Learn

• 1 Learn foundations of pharmaceutical production: process architecture, GMP principles, and production lifecycle stages.
• 2 Understand regulatory framework and quality systems: FDA/EMA requirements, ICH guidelines, CAPA, and change management.
• 3 Analyze facilities, utilities, and environmental controls: classification, HVAC, water systems, and containment strategies.
• 4 Explore unit operations in drug manufacturing: mixing, granulation, drying, compression, coating, and aseptic filling.
• 5 Apply process validation and lifecycle management: stages 1-3, continuous verification, and revalidation triggers.
• 6 Develop sterile and aseptic processing knowledge: cleanroom classifications, media fills, isolator technology, and sterile filtration.
• 7 Implement packaging, labeling, and serialization systems: blister packaging, barcode requirements, and track-and-trace compliance.
• 8 Integrate supply chain and cold chain management: supplier qualification, cold chain validation, temperature excursion handling.
• 9 Understand automation, data integrity, and Industry 4.0: SCADA, MES, ALCOA+ principles, and digital transformation.
• 10 Analyze continuous improvement, audits, and compliance strategies: Lean, Six Sigma, internal audits, and regulatory inspections.