GMP Quality Oversight of Your Investigational Medicinal Product

Synopsis

Do you have responsibility for the oversight of outsourced manufacture of Investigational Medicinal Products (IMP)?

This talk will introduce basic processes that support the qualification of contract manufacturers in your GMP supply chain. It will demonstrate sponsor oversight for effective management of risks associated with the manufacture of IMPs. Anonymised events at manufacturing sites that benefited from sponsor feedback by documented risk assessment will be given.

Start as you mean to go on. Make sound risk-based decisions when selecting vendors, confirming their GMP manufacturing process, and assessing events that occur during manufacturing by using a simple pragmatic quality system.