Validation

Course Overview

Module Information

This course is designed to give you an overview of Validation Master Planning and the Validation of systems & processes. This online learning environment is designed to be educational, engaging, and above all, simple to use. A short online assessment follows the module.

Learning Outcomes:
- Why we validate and the Regulatory requirements surrounding the manufacture of medicinal products.
- Validation master planning and documentation
- GMP facility, equipment and utility qualification
- Validation design, verification and qualification
- Process validation
- Cleaning Validation
- Pharma GMPs for the 21st century
- Post validation activities and maintaining the validation status
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