Webinar on Risk-based Outsourcing

Description :

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

Monitors

Data Management Team

Project Management Statisticians

Clinical Research Outsourcing

Drug Suppliers

All clinical research professional embarking on a risk-based approach