From the print-based process to managing with digital sytems. Case studies, tips and tools to optimise the process.
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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.
Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes