The Atlantic KET Med Project is bringing new, high tech, pilot production capacity to the EU Atlantic Area in support of SMEs and start-ups using the Key Enabling Technologies (KETs) to produce next generation medical devices. As part of the project Atlantic KET Med is delivering a rigorous quality management framework to enable SMEs to build and maintain their own GMP Quality Management System (QMS).
This introductory session (1 hour) will be delivered by Alastair Clarke as a blend of presentation and interactive discussion, introducing GMP and the wider Regulatory landscape. Alastair Clarke has been working closely with Atlantic KET Med to design and build a GMP Quality Management System providing a transferable framework to enable SMEs to implement and maintain a GMP QMS from scratch.
The QMS is designed to utilise a series of templates to ensure that all relevant information is gathered for GMP compliance, and it addresses the needs of global regulations as defined by national and regional regulatory authorities such as the EU (EMA) and the US (FDA). By getting started early with a Quality Management System you can proactively ensure that your product development programme will fulfil the needs of these regulations and standards, and avoid costly remediation and repeat work.
The session is FREE to attend and following the session, an attendance certificate will be issued. Click HERE to register.