Regulators expect that pharmaceutical professionals use risk management techniques and tools to manage product quality, manufacturing processes, validation and compliance within a risk-based Quality Management System. The ICH Q9 Guideline on Quality Risk Management is incorporated as GMP Annex 20 and Competent Authorities implement risk-based inspections.
Although an approach that has been widely used and is well established in other compliance related industry sectors, risk is still relatively new when applied to GMP. This introductory course will provide you with an overview risk-based compliance. It will illustrate how the application of risk in other areas, such as safety, can be applied to pharmaceutical manufacturing and GMP.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.