Risk Management and its application in GCP Environment Webinar
Register for our webinar on Risk Management and its application in GCP Environment.
Focusing on the principal of risk management and its application to the GCP environment. We outline risk management tools, application to GCP principal, what agencies have to identify during GCP inspection, and how to apply risk management during COVID19.
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Dorothée joined the company in May 2006 and has worked in regulatory affairs since 2003 mainly in human medicinal product, including small chemical entity and biotechnology products. Previously Dorothée was part of the CMC regulatory team at the manufacturing site of a major pharmaceutical company.
Dorothée’s current role is as Managing Consultant of the Irish office.
As part of the management team Dorothee has managed projects through the full product lifecycle from early development to product maintenance and MAH compliance. She has also supported several clients in preparation of inspection readiness. Dorothée oversees and manages our Irish office whilst providing expert consultancy to her client projects.
Niamh joined the company in June 2016 having spent 15 years working in quality compliance in the medical device sector initially as a QC Supervisor(2 years) before being promoted to QC Manager. Niamh also worked in the pharmaceutical sector from 1990 -2000 in both R&D (method development) and as a QC Chemist in a bulk pharmaceutical manufacturer.
Niamh’s current role in the company is as Regulatory Affairs Consultant.