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Pharmacovigilance and Quality services

About


What's in the name?

D1 Consultancy was founded by Astrid Deen in 2010. A 'D' and a '1' may be read as 'Done' in English, in Dutch it is read as 'Deen'. Together with the Consultancy, the name was born.

To date D1 Consultancy is still a one (wo)man company with the same ambition as it was founded with:
deliver quality projects, first time right.

With a steady growing network D1 Consultancy is able to get support from other consultants when needed.

Background

Astrid Deen started her career over 15 years ago at a manufacturing company (non food). In the role of logistic employee she got familiar with the different aspects of manufacturing and transport. After some temporary jobs in different industries she found a job in the pharmaceutical industry in clinical reasearch. Thereafter in different positions, different departments and in different companies she gained experience with the clinical, regulatory, drug safety and quality aspects of pharmaceutical products and devices. Recently she set her first steps in the food industry.

Since 2010 Astrid is working as a freelance quality consultant, familiar with GVP, GCP, GDP, GMP & ISO 9001. Her interest is in projects that focus on process improvement and quality assurance. Especially organizing, (re)structuring, defining business processes and documenting your processes in the Quality Management System drive her. Last year she gained experience with auditing activities. The next goal is to become (Lean Six Sigma) black belt certified.

Astrid can support on different levels from operational to tactic to strategic. On any level she will be result driven and have a systematic approach in which she pursues a high standard for herself and for others.

Her specialisation is:
  • Development of all kind of procedural documentation (Policies, Standard Operating Procedures, Work Instructions)
  • Peer review of new and present quality documentation (e.g. Agreements)
  • Process identification and mapping
  • GAP assessment of your (quality) system with the current and future standards and legislation
  • Risk based audit planning
  • CAPA management
  • Training programme development
  • Performance measurement and analysis
  • Continuous improvement (with use of the PDCA cyclus)
  • A little more about Astrid:
  • International work experience
  • Open, communicative and constructive approach towards the best possible result (problem-solving)
  • Analytic and precise, respecting company culture, human values and business standards and legislation
  • Team lead experience
  • Astrid is a member of the Research Quality Association (RQA).

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