34th SQA Annual Meeting and Quality College

DD-1  Next Generation Quality Management Systems 

Abstract:
With the adoption of the ICH GCP E6 R2 requirements and the latest industry guidance, it is important for sponsor companies and Clinical Research Organizations (CROs) to re-evaluate and implement an enhanced Quality Management System (QMS).  This session will provide information on recent changes to industry requirements, outline the components of a modern QMS, provide examples on how to apply the QMS at all levels of your organization and take a look at some upcoming industry trends. Session participants will be able to take this knowledge back in to their organizations, improve their QMS and better prepare for the future.
Each presentation will include real life examples and discuss collaboration between the Quality organization and key stakeholders. Topics covered in the session include:
-An effective QMS framework that encompasses regulatory requirements, industry guidance, and sponsor requirements
-A focused review of some key QMS elements – Quality Policy, Quality Manual, Risk Management, Business Continuity, Quality Oversight and Controlled Documents
-Overview and examples of how to put a robust QMS in practice at the partnership, program, and project level for effective quality oversight and first time quality performance of clinical trials
-A look to the future – eQMS, wearables, eInformed Consent, Real World Data

Attendees will gain knowledge about current QMS requirements, the QMS in practice and what to plan for in the future.  While requirements vary by country, company and business segment, every organization in the Biopharmaceutical space can benefit from the topics covered in this discussion.

Category:
Beyond Compliance

Level of Content:
Advanced