The team

Alexander Hönel

Mag. DDr. Alexander Hönel, MSc, LL.M., MBA

DDr. Hönel was 10 years Head of the Inspectorate & Enforcement Department of the Federal Office for Safety in Health Care, Austria, Europe (2004-2014), is currently Co-owner of a Gxp training company (GxP-konkret, since 2019) and CEO for INSA (Inspections & Audits), doing worldwide audits for mainly GCP, GMP & GLP and acting as Data Protection Officer for pharmaceutical companies.

Previously, he spent several years in Industry, Clinical Liaison Manager and Senior Medical Manager, and at the university as assistant.

In 2014 he founded Quality By Experts, The Inspectors Network, performing Consulting and Training Services as well as Audits in GCP, GMP, GLP, Blood, Tissue and Medical Devices, and Trainings (2014-2020).

During the time leading the Inspectorate, he was always active as inspector, in several areas of expertise like GMP, GLP, GCP, Blood and Tissues, Advanced Therapies, Medical Devices, Hemo- and Tissue Vigilance, Quality Defects and Drug Shortages, Pharmacovigilance, Narcotics (for OECD), Import of Medicines to Austria, Enforcement, doing several hundred inspections in the mentioned fields during these years, main areas Quality Management Systems in hospitals, assessment of Quality Assurance and Management Oversight.

As Head of Enforcement he established the link to police and border police, did speeches at congresses like for the WGEO (Working Group of European Enforcement Officers). In addition, for 10 years he was acting EMA Expert (for PHV and GCP), member in the Medical Devices Group, and PIC/S Executive Committee member. He is active member of the national Austrian Anti-Doting Agency (NADA).

Christiane Gebhard

Christiane is a Compliance, Quality and Risk Management specialist with several years of experience in the health-technology field. She holds a PhD in Biotechnology, after her academic career she moved to industry, leading business projects as Senior Scientist and Senior Regulatory Affairs Manager, in the start-up and corporate business environment.

Core competencies:

• Implementing quality and risk management systems

• Compliance and regulatory affairs guidance

• Internal and supplier auditing

• Improving key business processes

• Effectiveness analysis of quality and risk management structures

• Leadership and Lean Management support

In addition, Christiane works as university lecturer and external Auditor (Quality Management Systems according to ISO 9001, ISO 13485) on behalf of an international certification body.

Christiane is passionate about enhancing operational compliance, quality and risk effectiveness. She serves organisations to improve their regulatory management processes, to develop successful market access strategies and to establish sustainable business cultures aiming continuous improvements.

Quality, not quantity

They are working with us