Pharmaceutical Industry Course
This course offers practical guidance on launching generic oral solid dosage forms, covering GMP, regulatory compliance, bioequivalence, quality management, supply chain, validation, serialization, packaging, and cross-team coordination for safe and effective product launches.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This Pharmaceutical Industry Course provides a straightforward, hands-on guide to launching a generic oral solid dosage form onto the market with assurance. You will cover basics of GMP, regulatory submissions, bioequivalence, and quality management, progressing to procuring active ingredients and excipients, validating processes, preparing for inspections, implementing serialisation, handling packaging, logistics, and coordinating cross-team efforts for launching safe, compliant, and effective products.
Elevify advantages
Develop skills
- GMP & quality systems: put GMP, quality control testing, and corrective actions into practice in actual generic manufacturing setups.
- Regulatory dossiers: compile CTD, DMF, and ANDA documents for submitting generic drug applications.
- Tech transfer & validation: assist with scaling up production, process performance qualification, and verifying processes.
- Supply chain & sourcing: assess and approve suppliers of APIs and excipients while ensuring steady supply of materials.
- Serialisation & logistics: set up packaging systems, track-and-trace mechanisms, and temperature-controlled distribution.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workloadWhat our students say
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