The global regulatory landscape is constantly changing, and the increasing volume and complexity of regulations presents new challenges for manufacturers in regulatory management. Non-compliance can cause significant repercussions for any organization.
Developing a controlled regulatory management process will lead to a number of benefits; minimizing risk exposure and capturing business opportunities, while reducing costs. It will also allow organizations to manufacture and sell products with a longer regulatory compliance lifespan.
This eBook shares best practice knowledge in implementing a process approach to regulatory compliance management under these main points:
- Why take a ‘process’ approach?
- What is a regulatory compliance process?
- Costs to not having a regulatory compliance process
- The role of risk and who owns it
Author: Karl Dowling, Head of Regulatory Process Consulting
Karl Dowling has over twenty years’ experience leading quality and compliance process improvement initiatives. He has worked with Compliance & Risks for seven years helping world-leading industrial and consumer brands improve their regulatory compliance management.