Pharmaceutical Industry Course
This course offers practical guidance on launching generic oral solid dosage forms, covering GMP, regulatory compliance, bioequivalence, quality systems, API sourcing, process validation, inspections, serialisation, packaging, logistics, and cross-functional launch planning for safe and efficient market entry.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
This Pharmaceutical Industry Course provides a straightforward, practical guide to launching a generic oral solid dosage form onto the market with assurance. You will learn the basics of GMP, regulatory dossiers, bioequivalence, and quality systems, then progress to sourcing APIs and excipients, process validation, readiness for inspections, serialisation, packaging, logistics, and cross-functional planning for launch to ensure safe, compliant, and efficient products.
Elevify advantages
Develop skills
- GMP and quality systems: apply GMP, QC testing, and CAPA in actual generic manufacturing plants.
- Regulatory dossiers: prepare CTD, DMF, and ANDA files for generic drug submissions.
- Tech transfer and validation: support scale-up, PPQ, and process verification.
- Supply chain and sourcing: qualify API and excipient vendors and ensure steady material flow.
- Serialisation and logistics: implement packaging, track-and-trace, and cold-chain management.
Suggested summary
Before starting, you can change the chapters and the workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workloadWhat our students say
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