SANDRA WENIGER-NIEDERBERGER
The driving mentor
„When you want to build a ship, do not begin by gathering wood, cutting boards, and distributing work, but rather awaken within men the desire for the vast and endless sea.“
Antoine de Saint-Exupéry, The Wisdom of the Sands, Citadelle (1948)
The life sciences ecosystem enables us to do great things. It can heal, make life easier or detect serious diseases in their early stages – in every phase of a human life.
However, this perspective is often forgotten in concrete implementation projects. We are too far away from the actual purpose. My intention is to remind people of the purpose of our actions and regulations – but also to question them – in order to be able to approve and monitor therapies, drugs and medical devices quickly and effectively.
In order to determine the HOW, the WHY must be understood. It always thrills me to lead experts and young talents in line and project functions to sustainable success through this people-oriented approach.
SANDRA WENIGER-NIEDERBERGER
The driving mentor
„When you want to build a ship, do not begin by gathering wood, cutting boards, and distributing work, but rather awaken within men the desire for the vast and endless sea.“
Antoine de Saint-Exupéry, The Wisdom of the Sands, Citadelle (1948)
The life sciences ecosystem enables us to do great things. It can heal, make life easier or detect serious diseases in their early stages – in every phase of a human life.
However, this perspective is often forgotten in concrete implementation projects. We are too far away from the actual purpose. My intention is to remind people of the purpose of our actions and regulations – but also to question them – in order to be able to approve and monitor therapies, drugs and medical devices quickly and effectively.
In order to determine the HOW, the WHY must be understood. It always thrills me to lead experts and young talents in line and project functions to sustainable success through this people-oriented approach.
BACKGROUND
As a passionate compliance expert and advisor with a degree in business informatics and a CAS in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics, I have a proven track record of 17+ years in the pharmaceutical and medical device industry. I have led numerous national and international projects and have broad compliance expertise with perspectives from different frameworks. This experience enables me to develop individual solutions with my customers, be it for international corporations as well as for SMEs and startups. I catalyze significant value as project lead, mentor or professional expert at the interface between business, IT, quality management and regulatory affairs to shape the digital direction.
CONSULTANCY FOCUS
Interpreting and implementing risk appropriate regulatory
requirements, processes, systems and organizational structures
Empowering people with coaching and advisory in compliance topicsInterconnecting compliance with digital transformation projects
Leading projects to sustainable successs
Use cases in the areas of Quality and Regulatory Affairs,
Ethics and Compliance, IT, GxP, MDR, IVDR, ISO and CSV
BACKGROUND
As a passionate compliance expert and advisor with a degree in business informatics and a CAS in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics, I have a proven track record of 17+ years in the pharmaceutical and medical device industry. I have led numerous national and international projects and have broad compliance expertise with perspectives from different frameworks. This experience enables me to develop individual solutions with my customers, be it for international corporations as well as for SMEs and startups. I catalyze significant value as project lead, mentor or professional expert at the interface between business, IT, quality management and regulatory affairs to shape the digital direction.
CONSULTANCY FOCUS
Interpreting and implementing risk appropriate
regulatory requirements, processes, systems and organizational structures
Empowering people with coaching andadvisory in compliance topics
Interconnecting compliance with digitaltransformation projects
Leading projects to sustainable successsUse cases in the areas of Quality and
Regulatory Affairs, Ethics and Compliance, IT, GxP, MDR, IVDR, ISO and CSV
LIGHTHOUSE PROJECTS
Ensuring IT quality during the transformation to digital processes
During the merger of a global medical device manufacturer, I supported the local logistics center in ensuring regulatory IT quality during the transition from their manual to digital processes in the area of product labeling, warehouse management, cold chain processes, supply error management and quality controls to country specific registration information. I was responsible for ensuring compliance with applicable EU, FDA and company specific requirements by developing software validation strategies, feasibility assessments as well as designs of strategic application landscapes focusing on GxP critical records and their data integrity.
Analysis to achieve medical market approval as a digital health app
For a software as medical device I performed an analysis of the regulatory requirements in preparation for the German market access as digital health application (DiGA) according to the BfArM Fast Track approach. I was responsible for the analysis of the regulatory requirements including privacy, information security, clinical trial, safety, functionality and quality aspects, the documentary gap analysis between the MDD/MDR/DiGA legislations and the development of an approach for the clinical evidence assessment of the medical app.
Quality manager for an ISO 9001 quality management system
As quality manager of a consulting company I was responsible for 9 years in a leading role for the support and improvement of the quality management system. During this time, I successfully passed large and mid-sized customer-supplier audits focusing on GxP, ISO 9001/13485, value-added processes, IT security, employee training, and quality controls. I coached and consulted internal functions on business process analysis and modeling, and developed and delivered quality management/CSV training and workshops.
LIGHTHOUSE PROJECTS
Ensuring IT quality during the transformation to digital processes
During the merger of a global medical device manufacturer, I supported the local logistics center in ensuring regulatory IT quality during the transition from their manual to digital processes in the area of product labeling, warehouse management, cold chain processes, supply error management and quality controls to country specific registration information. I was responsible for ensuring compliance with applicable EU, FDA and company specific requirements by developing software validation strategies, feasibility assessments as well as designs of strategic application landscapes focusing on GxP critical records and their data integrity.
Analysis to achieve medical market approval as a digital health app
For a software as medical device I performed an analysis of the regulatory requirements in preparation for the German market access as digital health application (DiGA) according to the BfArM Fast Track approach. I was responsible for the analysis of the regulatory requirements including privacy, information security, clinical trial, safety, functionality and quality aspects, the documentary gap analysis between the MDD/MDR/DiGA legislations and the development of an approach for the clinical evidence assessment of the medical app.
Quality manager for an ISO 9001 quality management system
As quality manager of a consulting company I was responsible for 9 years in a leading role for the support and improvement of the quality management system. During this time, I successfully passed large and mid-sized customer-supplier audits focusing on GxP, ISO 9001/13485, value-added processes, IT security, employee training, and quality controls. I coached and consulted internal functions on business process analysis and modeling, and developed and delivered quality management/CSV training and workshops.