Speakers

I have worked within the pharmaceutical industry for over 30 years in R&D and previously manufacturing. A time-served analytical chemist who has been externalising development projects for over 20 years. Externalisation Subject Matter Expert with evolving expertise in Data Integrity with particular application in risk assessment of third party systems. Experience in technical delivery of pharma development projects from a diversity of global suppliers.
Increasingly interested in using technology solutions to achieve efficient data transfer mechanisms and to deliver dynamic data from the supplier.

Presentation Title: Challenges and Opportunities with External Data Management

Abstract: This presentation describes the specific challenges encountered when your data is generated within a partner's quality management system and discusses approaches to address the evolving regulatory expectations for data lifecycle management to ensure data security and integrity