Competences

GxP-Pharma Support A/S specializes in consulting and support within the fields of GxP and ISO.

Who we are

Lone Cleveland Andersen

The company GxP specialist and project manager, qualified pharmacist with extensive continuing education in project management and certified lead auditor for ISO 9001 and for ISO 17025 (laboratory).

In addition, the expertise continuously has been kept updated through conferences and other continuing education, hence the latest requirements within the pharmaceutical and biotech area are well known.

Our specialist has more than 20 years of broad, comprehensive national and international experience in drug production and distribution and is familiar with virtually all types GMDP- production areas.

In addition, there are 7 years of solid international regulatory experience as a medicines inspector in the Danish Health and Medicines Authority. In addition to inspections performed for the Danish Health and Medicines Authority, our specialist has conducted inspections in countries outside the EU, on behalf of EMA and has also participated in several international meetings in EMA and PIC/S network.

This in-depth knowledge is for the benefit of your company

The overview shows in detail the various tasks that are the foundation of the company’s core competences. For more information and list of courses grouped by fields of competence, are available on request.

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Jan Laursen

Daily administration, IT and finance. Jan is an economist with over 30 years of experience in the process industry and company operations.