Pharmaceutical Industry Course
4.3/5
This course offers practical guidance on launching generic oral solid dosage forms, covering GMP, regulatory compliance, bioequivalence, quality management, sourcing, validation, inspections, serialization, packaging, logistics, and cross-team coordination for safe and effective product launches.
4.3 in rating
flexible workload from 4 to 360h
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, then proceed to sourcing 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 and quality systems: put GMP, quality control testing, and corrective actions into practice in actual generic manufacturing setups.
- Regulatory submissions: compile CTD, DMF, and ANDA documents for generic drug approvals.
- Technology transfer and validation: assist with scaling up production, process performance qualification, and verifying processes.
- Supply chain and sourcing: assess suppliers of active ingredients and excipients to ensure steady material supply.
- Serialisation and logistics: set up packaging, tracking systems, 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 workload.What our students say
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Giulio CarloDigital Marketing Student
I like how the lessons are straight to the point and how I can change chapters and skip content I don't need.
Mariana FerresPhotography Student
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