BioPharmaChem Skillnet

Certificate in CPD in Manufacturing of Pharmaceutical Formulations Level 9

Certificate in CPD in Manufacturing of Pharmaceutical Formulations Level 9

1,000.00 (member rate)

This course takes place part time over 8 weeks and  it provides participants with knowledge and experience in the manufacture of pharmaceutical dosage forms containing both small organic molecule and biopharmaceuticals under sterile, validated and regulated conditions. Providing participants with technical and practical knowledge of the formulation and delivery approaches for the development of pharmaceutical dosage forms and how those approaches influence the safety, quality and efficacy of the pharmaceutical products.

Date: October 2023

Out of stock


Course Content:
• An overview of therapeutic agents – from small to large molecules and biologics.
• Pharmaceutical formulations and routes of delivery.
• Unit processes involved in the production of drug substances and dosage forms.
• Practical aspects and applications in the processing and control of sterile pharmaceutical products.
• Registration and licensing requirements for new medicinal products and facilities.
• An overview of cGMP requirements in the regulations.
• Design and validation of pharmaceutical processes.

Programme Learning Outcomes:
On successful completion of the programme, students should be able to:
• Describe the formulations and routes of delivery appropriate for different therapeutic agents.
• Assess unit operations involved in the production of drug molecules and how they affect the product quality attributes.
• Evaluate how current regulatory practices ensure the quality, safety and efficacy of the pharmaceutical drug products.
• Discuss how the GxP principles are integrated within the quality management system of pharmaceutical organisations.
• Discuss the lifecycle approach of the pharmaceutical process validation.

This course is delivered part-time by a combination of blended online learning approaches that involve recorded introductions to course topics, workshops, discussion boards and webinar tutorials. Students are expected to undertake self-directed study in advance of workshops and webinars, and continuous assessment related assignments.

To apply, a candidate must have obtained at least a Second Class Honours primary degree in a relevant Pharmacy, Science or Engineering discipline (NFQ level 8). Consideration will be given to other applicants with sufficient equivalent professional qualifications and significant industrial experience. These applicants will be reviewed by the Programme Lead on the basis of their relevant work experience and motivation statement.

All applicants whose first language is not English are expected to have a minimum IELTS score of 6.5, with no individual section lower than 6.5.