Quality Assurance & Good Manufacturing Practice

Course Overview

Module Information

This module is an introduction to Quality Assurance and Good Manufacturing Practice. The short learning module is designed to give participants an overview of Good Manufacturing Practice (GMP) and the Quality System used in the manufacture of medicinal products. This online learning environment is designed to be educational, engaging, and above all, simple to use. When this course has been completed a short online assessment can be taken

Learning Outcomes:
- An understanding of Quality, regulatory bodies and regulations.
- Understand the purpose of the Pharmaceutical Quality Management System as well as a thorough knowledge of Quality System Elements. (QSEs)
- Understanding of each Quality System Element of QA, Premises and Equipment, Calibration, Technology transfer and training.
- Familiarity with the Quality System Elements in relation to Documentation, Supplier qualification and QC testing and stability.
- Knowledge of Quality System Elements of Validation, Change Control, Investigations and CAPA.
Lecturers

Luke Kiernan

Luke has over 20 years of experience within the pharmaceutical manufacturing industry, having previously worked with Pfizer, Wyeth, Elan and Gerard Laboratories. Luke has held various management roles, in Technical Services, Validation, Process Development, Regulatory Affairs, Analytical Development, Quality Control and Quality Assurance. Luke holds a BSc in Chemistry from the University of Glamorgan and an MSc in Instrumental Methods of Analysis from Dublin City University

Audrey Meehan

Audrey has over 15 years of experience within the pharmaceutical manufacturing industry, having previously worked with Elan, Wyeth and Pfizer. Audrey has held various management roles, in Technical Services, Validation and Process Development. Her experience includes: Validation Master Planning, the validation of large capital expansion projects, Technology transfers, the revision of systems in response to new regulations and employing Lean tools. Audrey holds a BSc in Chemistry from the University College Cork.
Career Options
Module Fees

€ 100