The regulatory background for the Pharmaceutical industry as a whole now requires a ‘risk based approach’ to all activities and that will of course include Outsourcing. Lack of Outsourcing Oversight is a very common finding during audits and regulatory inspections. One vital part of outsourcing is establishing adequate auditable documentation.
This course provides an understanding of risk management principles and makes the links necessary between them and the processes necessary for effective outsourcing.
Areas Covered in the Session :
Review the clinical outsourcing and the 5 steps of risk management
Outline why a ‘risk-based approach’ is necessary in vendor management
Review the process of vendor management and apply a risk based approach
Prioritise risks and plan mitigation actions during the vendor selection process
Examine the challenges with multiple contractors, 3rd party outsourcing and working with Academia
Who Will Benefit:
A must attend webinar for all:
Clinical Research Associates
Data Management Team
Project Management Statisticians
Clinical Research Outsourcing
All clinical research professional embarking on a risk-based approach