BIOGRAPHY


Pia Lise Sandau

Pia Lise Sandau Team Leader, Novo Nordisk A/S, Soeborg, Denmark


Pia Lise Sandau Team Leader, Novo Nordisk A/S, Soeborg, Denmark Biography - Sandau, Pia Lise (Speaker) Pia Lise Sandau has worked with Quality for the past 16 years. She began her career with Novo Nordisk A/S in 1981 after having received her B.Sc. degree as Medical Laboratory Technician. During her career at Novo Nordisk, she took the education as Pharmaceutical Consultant, ISO 9000 Lead Auditor and Project Manager. Mrs. Sandau has been working in the research area within protein chemistry, pharmacokinetics and biotechnology areas for ten years as a laboratory technician. Mrs. Sandau has been the driving force behind numerous quality initiatives within Novo Nordisk, as quality manager establishing the Quality Management System in Regulatory Affairs and guiding them through an ISO certification; implementing new templates for operational documents; starting a SOP Expert Group for writing operational documents; creating an Innovation Group in Regulatory Affairs. In the Research and Development organisation she has as quality specialist and project manager implemented ISO 9001:2000 for the development processes; rebuilding the Quality Management System following a reorganisation; and putting the electronic training and documentation system “ISOtrain” into operation. In addition she is responsible for maintaining the organisation’s ISO 9001 and 13485 certification and ensuring compliance to the Quality Management System within Research and Development. She has participated in improving the QMR process with new agenda and new meeting set-up thought the whole organisation. She has spent numerous hours educating others in the QMR principles and planning and performing QMR’s. During the past two years Mrs. Sandau has been a part of a bigger project at Novo Nordisk focusing on a more robust and simple quality management system. She has been heading of a project there should reduce number of Standard Operating Procedures (SOP’s) for all employees and ensured that no one was reading unnecessary SOPs. In the research area her and her team have implemented a differentiated QMS, with a clearer split of responsibilities between research personnel and her QMS team. The team is covering the nonconformities, conducting SOP review, handling CAPA forum for the medical devices, handling electronic training of all employees and act as project managers for a lot of important quality projects. Mrs. Sandau is now team leader for a quality team, covering support and being QA for most areas in R&D including top management. Mrs. Sandau has previously presented at the International Conference on ISO 9001 and QMS tree time. In 2007, she spoke on “Does a successful certification automatically lead to successful maintenance?” and in 2009, the topic was “How do we ensure that ISO 9001 and Lean® in R&D is working hand in hand?” and in 2011 “Optimal QMS organisation provides the right customer focus” Ms. Sandau has co-authored two articles: Application of the Euglycaemic Clamp Technique to Bioassay of Insulin Analogues and Implementation of ISO 9001:2000 for Development Processes at Novo Nordisk A/S. Conf No: 96535896 ISO Conf: Checked LSS Conf:

 

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“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013