Module Overview

Regulations for the Workplace and Community Based Learning

The aim of this module is to introduce the student to the requirements of the legislation which 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, HPRA, EMA) (medicine safety) will be outlined.
 
The Community Based Learning section of this module gives the student the experience of undertaking a project that benefits their community and enhances their understanding of the course material. In addition, students will develop a range of key transferable skills that are currently essential for the workplace, including organisation, digital literacy, communication, problem solving and teamwork skills.
Module Code

CHEM 2015

ECTS Credits

5

*Curricular information is subject to change

 

 

 

 

 

Health & Safety

Distinction between criminal and civil liability Origin of health and safety legislation in Ireland The Safety, Health and Welfare at Work Act 2005 and relevant RegulationsDuties of employers and employees Specific legislation and requirements relating to hazard and risk communication Use of chemicals in the workplace Introduction to OHSAS 18001 and 18002.

Quality and GMP in Industry

Introduction to quality, rise of the concept of quality, quality versus regulation in industry GMP Regulation and Regulatory authorities in Ireland, EU, USA Documentation Control, Personnel, Quality Control, Quality Assurance, deviations, product recall, complaints, role of QP Introduction to ISO/IEC 17025 Good laboratory practice, laboratory records, and weighing Sampling and sample types Methods and method validation, accuracy, precision Measurement Traceability & calibration Materials management

Community Based Learning

Development of experiments and hands-on activities to demonstrate scientific principles to children of school-going age. Reflection on the effectiveness and content of the presentations, development of their transferable skills and the role of professional chemists in society. An alternative activity can be availed of by students who are interested in preparing for and coordinating class visits by their peers and assisting in the preparation of a press release / video on the activities undertaken. Further details can be obtained on contacting the laboratory supervisor.

The module is delivered through a series of lectures (20 hours), tutorials (4 hours), laboratory practical classes/ community based learning (15 hours) and self-study (61 hours).

Module Content & Assessment
Assessment Breakdown %
Other Assessment(s)100