The aim of this module is to introduce the student to the requirements of the legislation that will impact on their work in the chemical and pharmaceutical industries. Health and safety legislation and the regulatory requirements involved in monitoring of the quality of medicines (Good manufacturing Practices (GMPs) will be explored. The role of the HSA (worker safety) and regulatory bodies (FDA, IMB, EMA) (medicine safety) will be outlined.
The professional development section of this module is designed to equip the student with the skills necessary to secure a placement. Interview skills, CV and LinkedIn preparation will explored in a series of workshops.
Health & Safety
Distinction between criminal and civil liabilityOrigin of health and safety legislation in IrelandThe Safety, Health and Welfare at Work Act 2005 and relevant RegulationsDuties of employers and employeesSpecific legislation and requirements relating to hazard and risk communicationUse of chemicals in the workplaceIntroduction to OHSAS 18001 and 18002.
Quality and GMP in Industry
Introduction to quality, rise of the concept of quality, quality versus regulation in industryGMP Regulation and Regulatory authorities in Ireland, EU, USADocumentation Control, Personnel, Quality Control, Quality Assurance, deviations, product recall, complaints, role of QPIntroduction to ISO/IEC 17025Good laboratory practice, laboratory records, and weighingSampling and sample typesMethods and method validation, accuracy, precisionMeasurement Traceability & calibrationMaterials management
Professional Development
Career planning. CV preparation, LinkedIn.Opportunity search, including networking, Interview skills. Placement preparation.
The module is delivered through a series of lectures (20 hours), tutorials (4 hours), practical classes/workshops (15 hours) and self-study (61 hours).
Interactive Group Learning will be facilitated through discussions, group work, role-plays, oral presentations, viewing of appropriate videos, internet exploration and some lecture input.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |