Ursula Koller

GMP expert


Dr. Ursula Koller has a sound professional experience as a GMP inspector at the Austrian BASG/AGES, which is in charge of sovereign duties in the field of regulatory and inspection on behalf of the Austrian government.

She has conducted numerous regulatory GMP inspections on national level, both API and FDF producers, wholesalers, supply chain and QC labs. Moreover she was responsible for API and FDF inspections abroad in many countries in Asia, The Americas and non-EU-countries.

She has expertise with supplier qualifications for her clients in EU countries and non-EU counties like India, China, Bangladesh, Thailand, Vietnam, Philippines, Israel or Brazil; she is familiar with cultural differences in these countries.

She performed more then 170 audits during the last 6 years, e.g. active pharmaceutical ingredients, bulk ware manufacturers, finished dosage forms, packaging materials or excipients.

Furthermore she provides QA support for clients by compiling and updating of Quality Assurance documentation, like SOPs, Site Master Files, etc. and supports pharmaceutical companies during facility upgrades and preparations for regulatory inspections.

Studying Pharmacy she graduated as a PhD at the University of Vienna, Austria followed by a career in the pharmaceutical industry, where she worked for GlaxoSmithKline and Sandoz. She is a certified EOQ Quality Auditor and Quality Systems Manager. Apart from her background as GMP specialist, she has sound knowledge in the areas of medical, quality assurance, or strategic sourcing of APIs.


Her trainings:


Qualified EU GMP inspector by the Austrian Health Agency AGES since 2005; trainee phase as a GMP auditor including participation in GMP audits together with recognized experts (2009). Qualification is maintained by regular evaluations and participation on GMP trainings offered by recognized organizations, like Concept Heidelberg, ECA, PDA or ISPE. Besides cGMP (APIs, Medicinal Products) and related topics, regular training covers GDP, excipients, and packaging materials.



Services:


o    Analysis of the current GMP status of a site
o    EU-related mock inspections, self inspections and internal audits
o    Assistance in preparation for regulatory/authority audits by EU agencies
o    Quality assurance system related services
o    Supplier qualifications of APIs producers and contract manufacturers
o    GMP assistance for due diligence projects