October 19, 2017 : Tech Talk NNE – Quality Risk Management System (Q-RMS)
NNE is an international company specialised in pharma engineering. Through focused pharma engineering we enable our customers to deliver on demand, bring products to market by providing flexible, compliant and future-proof solutions.
NNE has decided years ago to focus more its know-how in Pharmaceutical Engineering on patient and on product by better understanding the relationship between Process, Product and Patient. This understanding is increased using Science and Risk Assessment.
This is why NNE has developed its own Risk Assessment Approach, compliant with the latest regulatory requirement, science based and applicable at all stages of a project from Conceptual Design to Process Validation and beyond. This approach relies basically on a tool called Quality Risk Management System Q-RMS.
This tool helps NNE in the following:
. To focus on the main purpose of Biopharmaceutical Industry : Patient Safety & Product Efficacy since the earliest stage of a project.
. To better consistently and systematically orient Process Design and Qualification towards Product and Patient by better controlling sources of variation and thus potential Quality Risks.
. To take advantage of previous accumulated product and process knowledge to reduce Quality costs and Qualification effort to just necessary risk related scope and avoid Costly Over Quality.
. To comply with the last regulatory recommendations on Process Validation.
This approach is now applied in multiple countries in Europe, Asia and the US and NNE Commissioning & Qualification Strategies are now based on it. This approach gives the customer a better understanding of his own processes and eases projects by focusing on critical points of Quality at all time.
This topic will be share with NNE’s team Houssam Benyettou (Pharmacist), and Cécile Paturel (Account Manager)
Start at 9 am in Accinov facilities