The Management of Deviations in Life Science companies

Why take part?

Deviations in Life Science companies are very frequent and arise when unexpected events or problems move away from an approved GMP process and/or from what is required/accepted in GMP.

Deviations have a significant impact on the entire corporate system. They can block or reject entire batches, involve multiple departments in investigations, and generate preventive corrective actions that affect the entire company.

They also need very careful handling because they can impact the identity, strength, quality, purity, safety, efficacy, performance, reliability, or durability of a medicine or device. This is one of the reasons why deviations receive so much attention during inspections.

On the basis of this premise, we have developed the free webinar entitled “The management of deviations in Life Science companies”.

Supported by experts in the field, we will explore with examples and case studies the deviation process, inspection requirements, monitoring, difficulties and tips for optimising it.

We will also give a practical demonstrationof the digitisation of the process on the PRAGMA-WFM platform, which is cGxp and FDA compliant, and allows you to remotely manage deviations anywhere, execute activities, monitor performance, and generate reports and dossiers.

In addition to providing useful ideas and tools, the Webinar aims to generate constructive discussion with the participants, who will be able to ask questions to the experts during the event.

Agenda