NSF’s executive director and ex-inspector at the medicines and healthcare products regulatory agency (MHRA) Rachel Carmichael will be speaking at the Outsourcing and Supply Chain PDA Europe conference this November in Seville, Spain.
Taking place from 6-7 November, this newly designed conference covers the whole supply chain from raw materials to last-mile distribution.
Rachel’s session on 6 November will focus on effective good practice (GxP) data integrity governance in complex supply chains.
Despite pharmaceutical data integrity governance being an area of extreme regulator focus for a decade, each year ever more dramatic issues are identified as more problems surface. Using a detailed analysis of the US Food and Drug Administration’s FDA warning letters, Rachel will consider whether we are learning as an industry.
Based on different industry associations and personal experience, Rachel’s session covers:
- The available tools to improve data integrity governance and management oversight considerations
- Hints and tips for you to enhance and make your data integrity audits more effective
- What we all should be doing now to minimise the risks