GxP Outsourcing: Ensuring Compliance and Quality in Your Operations

Course Overview

Oversight is important for the client and the contract manufacturing, packaging, or testing site. The MAH or CT Sponsor is ultimately responsible for the product. Therefore they must maintain scientific, quality, and regulatory oversight to ensure that their companies’ internal standards and the regulator’s expectations are met.

By delegating their responsibility to the contractor, they have a duty of care to ensure that they meet the requirements regarding the quality, safety, and efficacy of the product, whether it is a commercial marketing authorisation or a new molecule being investigated as part of a clinical trial.

So how to engage with your partner organisation be it a consultancy or logistics partner, and how to ensure the right contracts are put in place, qualifications completed, QTAs put in place, and QP-QP agreements drafted is critical.

In this one-hour webinar, we will guide you through the ongoing assessments and reviews, PQR/APR product quality reviews, risk assessments, audits, and ongoing communication and oversight requirements, as well as give you insight into what to prioritise and work on when developing their relationship with the existing partners. We will talk you through how to engage with your partner organisations be it consultancies or logistics partners and how to ensure the right contracts are put in place, qualifications completed, QTAs put in place and QP-QP agreements drafted.

Don’t miss this exclusive webinar, register now and Join us on 31 May 2023 to ensure you maximise communication and oversight of your contracted operations and deliver real value to your organisation!