Key concepts and requirements for a successful implementation
The Atlantic KET Med Project is supporting 25 SMEs across the Atlantic Area with targeted technical support which will be delivered by one or more Partners in the Consortium. Atlantic KET Med’s GMP Quality Management System (QMS) brings rigour to the way the technical support will be delivered, ensuring compliance with the necessary regulations and standards.
Working with Atlantic KET Med will ensure that your development project will fulfil the needs of these regulations and standards, proactively benefiting timely delivery and limited expense by avoiding remediation and repeat work. The QMS is designed to utilise a series of templates to ensure that all relevant information is gathered for GMP compliance. The QMS addresses the needs of global regulations defined by national and regional regulatory authorities such as the EU (EMA) and the US (FDA).
This first training module will provide an introduction to the AKM Quality Management System and will cover Admin Project (the repository for the QMS), Project Context, the Quality Manual, SOPs (Access Procedures and Document Control), Templates (and their use to define and then control the product and process) and finally GMP (a reminder of responsibilities when performing Atlantic KET Med work). Following the session, a Q&A document will be sent for completion and return by the participants. This will be marked and returned with any corrective work identified and the final document will be stored as a formal training record.
10.00am – 11.30am UK time