Presentation given at the 2019 ASQ Audit Conference.
The Pharmaceutical Quality System described by the International Conference of Harmonization (ICH) is a holistic approach which facilitates the consistent development and production of high quality pharmaceutical products. It aims to support innovation and continual improvement of products, processes, and methodologies using knowledge management and quality risk management. Providing a lifecycle approach to pharmaceuticals, change management is a key element to this approach.
The Pharmaceutical Industry is one of the most regulated industries. In the US, the Food and Drug Administration (FDA) often uses the consent decree as the ultimate enforcement tool for those who break the rules. A company under consent decree needs to prove, via third party, that it has achieved and can sustain regulatory compliance. Companies under a consent decree must break down and build up their entire quality system.
After this session attendees will be able to:
- Evaluate lessons learned from a consent decree and building a robust pharmaceutical quality system for your use.
- Explain how the pharmaceutical experience can deepen your understanding of ISO 9001:2015, especially risk based thinking
- Identify how change management fits into a culture of quality
- Understand how the change management system increases compliance
- Use a few simple but effective tools for change management.
The ICH quality approach developed from ISO 9001:2008 but in many ways preceded the risk based thinking pivotal to ISO 9001:2015. Utilizing a matrix of similarities and differences between traditional GMPs, the ICHs and ISO 9001:2015, we will explore several lessons learned from consent decree activities, and demonstrate principles of change management.
This session will explore change management from the three lenses of science, regulation and risk, with a focus on knowledge management and risk management as enablers of successful change management. Several examples will be shared to demonstrate the fundamental connections between these systems.
The basis of this session will be change management as a fundamental part of a culture of quality. We will share best practices based on lessons learned from the consent decree around the impact of cumulative changes and large-scale versus incremental change.
Compliance for change management necessitates clear accountabilities, prioritization of changes, and the role of the quality unit – including the importance of a change champion or steward. This session will explore the relationship between change control, which often refers to the execution step of an individual change, and change management, which is a more systematic, holistic approach to the review and management of a portfolio of changes and the change process.