Course Introduction
The course is made up of seven learning modules and looks at the need and requirement for a risk-based quality system and how they were initially developed for the automotive and aerospace industries. It considers the International Conference on Harmonisation (ICH) guidelines and how they support the development and implementation of a successful quality system .
Course Key Points
- The requirement for a risk-based approach to quality management and the driving forces for robust quality systems
- To investigate the essential elements of a robust quality system for the pharmaceutical industry compared with similar models produced for other high-tech industrial sectors
- To look at the three relevant guidelines - ICH Q8, Q9 & Q10 and how these support the development and implementation of a robust quality system
- To describe the core elements of robust quality systems
- To evaluate how robust quality systems can reduce exposure to regulatory non-compliance
Course Author
Allison Jack, Pharmacovigilance Quality Assurance Manager at GlaxoSmithKline, Stevenage, UK is a member of the Good Pharmacovigilance Practice Committee of the RQA. Allison previously worked at Pfizer in GCP and Pharmacovigilance Quality Assurance and prior to this in various clinical supply chain roles whilst at Pfizer. She has also been chair of the RQA Good Pharmacovigilance Practice Committee, the Quality Risk Management Working Party and served on various conference programme committees for RQA's annual conference, as well as presenting at specialist meetings and international meetings and conferences. Allison is also course principal for the RQA Systems Audit Course.