Every pharmaceutical company has GMP and SOP training. It helps members of the organization to know how to behave in most if not all situations. Issues not directly addressed in an organization will be discussed between the different parties, typically with input from the Quality and/or Regulatory organization. For many mature organizations this arrangement leads to good Quality Decision Making leaving the company ready to deal with regulatory scrutiny.

 

However, for a variety of reasons, in some cases this constant dialog breaks down and Quality Decision Making is typically the first victim of such breakdown. Rather than seeing each other as partners, the various stakeholders create solutions that are isolated from the overall business and quality objectives. Over time, such situations almost always lead to regulatory scrutiny, if not action.

 

For one client QORM Consultants developed an Integrative Engagement Training approach that helped to  improve the this situation dramatically. Rather than focusing on specific SOPs or regulatory requirements, this training employs a conceptual approach focusing on learning, application, and sharing of quality objectives throughout the organization.