LAW07026 2019 Legislation, Quality & Auditing Systems

Demonstrate a detailed knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMA in relation to medicinal products.

Integrate knowledge and understanding of Common Technical Document (CTD), variations procedures and Clinical Trial Legislation to evaluate relevant case studies.

Source and evaluate guidance procedures and directives currently regulating good manufacturing practices (GMP).

Demonstrate knowledge of the ICH Q9 and Q10 guidance documents as relating to QRM and PQMS for a licensed production facility.

Interpret and understand the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical and medical device products in a GMP environment.

Source, interpret and apply GMP principles to different case scenarios and identify potential issues that would result in implementation of Corrective and Preventative Actions.

This module will be delivered full time. This will include lectures, and site visits augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a potential means of assessment (e.g. quizzes, uploading assignments and journals).

This module will be assessed using a combination of end of semester final exam (60%), continuous assessment and course work (40%).

The continuous assessment and course work will involve Short Answer Questions/Multiple Choice Questions/Assignment Work where students will be required to (i) demonstrate an understanding of core module concepts, and (ii) presentations on topics which demonstrates the student's ability to critically evaluate an aspect of the subject area. there will be a number of MCQs given during the semester

Repeat Continuous Assessment and/or Final Exam.

1 Demonstrate a detailed knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMA in relation to medicinal products.

History of Regulatory Affairs, Definitions, Regulatory framework, GMP.

Introduction to European and US legislation & terminology, Licenses required. Principal competent authorities Ireland/EU/USA.

2 Integrate knowledge and understanding of Common Technical Document (CTD), variations procedures and Clinical Trial Legislation to evaluate relevant case studies.

CTD & Clinical Trial Legislation, ICH guidance, Eudralex Vol. 2.

3 Source and evaluate guidance procedures and directives currently regulating good manufacturing practices (GMP).

ICH guidance, Eudralex Vol. 4. + Annexxs

4 Demonstrate knowledge of the ICH Q9 and Q10 guidance documents as relating to QRM and PQMS for a licensed production facility.

Quality Risk Management process and Pharmaceutical Quality Management System.

5. Interpret and understand the relevance of auditing as a means of monitoring the production of safe and efficacious pharmaceutical and medical device products in a GMP environment.

Introduction to GMP and Auditing. (QP role, QMS and role of audits in a GMP environment).

Quality systems. Corrective and Preventive actions (Containment, correction, effectiveness checks), Change Control, Validation, Training, Calibration, Documentation, EHS, Lean Six Sigma/continuous improvement.

5 Source, interpret and apply GMP principles to different case scenarios and identify potential issues that would result in implementation of Corrective and Preventative Actions.

Audit Process- Audit types, techniques, auditor role. Auditing tools, Audit phases, Audit Agendas, Audit preparation, questionnaires and checklists.