Official speaker

linda

hendy

Standard Development Manager

National Standards Authority Ireland (NSAI)

Linda is a Standard Development Manager with the National Standards Authority Ireland and manages a number of national standard committees in the Healthcare area. This work involves monitoring international standard developments in many areas relevant to healthcare and lifescience including Biotechnology and biobanking, genomics, medical device safety, sterilization, clinical laboratory testing and health informatics. Linda works with national stakeholders to provide feedback on behalf of Ireland on the development of International standards. Prior to working in standard development, Linda worked as an auditor with NSAI certification and Notified Body, carrying out quality management system audits and reviewing technical files as part of the CE Mark approval process for medical devices. Prior to joining NSAI Linda also worked in the medical device industry as a Quality and Regulatory Affairs Manager.

Panel Sypnosis

"Unlocking Value: Standards in Biopharma and the Lifesciences"As the biopharma industry navigates the rigorous terrain of regulatory compliance, the role of voluntary standards, such as those set forth by the International Standardization Organization (ISO), often remains underutilized yet powerful in fostering quality, innovation, and long-term resilience. This session, co-presented by a representative from the National Standards Authority of Ireland and an expert and assessor in biobanking and ISO biotechnology standards, will shed light on the strategic benefits that standards can bring beyond baseline compliance. Relevant standard developments for biopharma and lifescience will be highlighted e.g., ISO 20387 for biobanking, ISO 14644 series for cleanrooms, emphasizing how standards can enhance operational effectiveness and optimize bioprocessing. Engaging in standard development is a great way to keep up to date on new developments relevant to the Biopharma and lifescience sector. Participants will leave equipped with practical approaches on how to keep up to date on relevant sector standards and how to integrate voluntary standards as a strategic resource for future-proofing operations.