Certificate in CPD in BioPharmaceutical Technologies
€1,950.00 (member rate)
This NFQ Level 9 Certificate in (Bio)Pharmaceutical Manufacturing and Regulatory Sciences is designed for science, engineering and healthcare graduates who hold a NFQ Level 8 qualification and who wish to receive targeted upskilling in the (Bio)Pharmaceutical and Pharmaceutical sectors. Provision will also be made for candidates who hold sufficient previous educational/professional experience. The programme aims to provide participants with knowledge and experience in the manufacture of active Pharmaceutical ingredients (both small organic molecule and BioPharmaceuticals) under sterile, validated and regulated conditions. Students will receive technical and practical knowledge of the key upstream and downstream processes associated with the industry, and the formulation and delivery of biological drugs
Out of stock
Description
The programme’s 10 credit module will consist of approximately 23 direct contact hours (the equivalent to approximately 3 full days) comprising:
- 12 hours of lectures;
- 8 hours of tutorials;
- 3 hours of workshops.
It is also anticipated that students will complete 60 hours of directed study with programme materials and approximately 117 hours of self-directed.
Learning Outcomes
On successful completion of this programme, students should be able to:
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Describe the formulations and routes of delivery appropriate for different therapeutic agents.
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Assess unit operations involved in the production of drug molecules and how they affect the product quality attributes.
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Evaluate how current regulatory practices ensure the quality, safety and efficacy of the pharmaceutical drug products.
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Discuss how the GxP principles are integrated within the quality management system of pharmaceutical organizations.
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Discuss the lifecycle approach of the pharmaceutical process validation.
