The Worldwide Safety division of a global pharmaceutical company needed to develop a global approach for assessing and remediating all Customer Engagement Programs (CEPs) in response to FDA and EMA inspection findings. We developed the process based on significant experience with customer engagement program regulations and exceptional process design skills.
We designed a process to bring all CEPs up to company safety reporting policy – including thousands of programs in 82 countries. We developed a remediation process which was agreed upon by all key global stakeholders. Our team managed the determination and categorization of programs on a compliance spectrum. Subsequently, we managed necessary program corrective action that needed to be applied Finally we developed a comprehensive SharePoint site that incorporated all program documentation for quick and easy navigation by outside regulatory agencies.
The remediation actions and inspection-ready documentation of these actions resulted in a successful re-inspection by FDA resulting in the removal of the warning letter.