Meet the Pharma IT Academy Instructors!

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Meet the Pharma IT Academy Instructors!

The Pharma IT Academy philosophy begins with our instructors. We believe our practicing industry veterans provide an unmatched opportunity for participants to learn how course concepts are utilized in the field. Dorte, Torben, and Stine (pictured left to right) have worked in the pharma industry for decades. Now they bring their experience to you! Below you can learn more about each of their backgrounds.

Torben Elhauge

Torben Elhauge has more than 25 years’ experience in GMP regulated areas and holds a master’s degree in chemical engineering. He has broad experience within all parts of the CMC area – from development over validation and registration to GMP release of products. He has in-depth knowledge of the regulatory landscape and worked at the Danish Medicines Agency for more than 6 years. He has also worked within the QA area, conducting GMP training and audits.

He has extensive training experience lecturing for the MIND at KU, Pharmakon, Lægemiddelstyrelsen, as well as internal GMP related courses for several Pharma IT customers.

As the Director of the Chemistry, Manufacturing, and Control (CMC) Team at Pharma IT, he supports our customers with strategic leadership and hands-on work to get them to market. This includes: strategy development, project management, analytical development, formulation development, CMO selection, audit, and writing/reviewing Module 3, and more!

Dorte Juul

Dorte Juul holds more than 15 years’ experience within the IT compliance area, working in both the pharmaceutical industry and food ingredients sector, and is highly specialized in GxP. She has performed in leading roles, such as Validation Track Lead on projects, as well Service and Release Manager on production systems. Dorte holds a master's degree in International Business. She has SAFe Agilist, SAFe Scrum Master and CISA certifications as well as an ITIL Foundation Certification and certifications as Computer Validation Manager and Lead Auditor.

She currently works as a Principal Consultant at Pharma IT, where she provides our customers with expert assistance with:

  • Compliance and Validation Test Management
  • Service Management and Release Management
  • Operation and Maintenance of GxP systems
  • Assessments and Business Analysis
  • Project Management
  • Offshoring and working in cross-cultural teams

Stine Kristensen

Stine Kristensen has more than 15 years of pharma industry experience working with IT Compliance, IT Implementation Projects, and System Administration. She has worked both as an external consultant and as internal staff for biotech, pharmaceutical and pharma-related device companies. Stine has worked as IT QA in operation and project phases for computerized systems and Validation Track Lead, as well as in GxP system/infrastructure operation and maintenance.

She holds a CISA certification, a SAFe Scrum Master certification, and is trained as Lead auditor for internal and external audits.

As a Principal Consultant at Pharma IT, she provides our customers with expert assistance with:

  • Computer Systems Validation (GAMP5, 21 CFR Part 11, EU Annex 11)  
  • Quality Control and Validation Support according to the V-model including deep knowledge about:
  • Quality/Validation planning and reporting  
  • GxP risk impact assessments / Risk register  
  • Data integrity assessment  
  • IQ/OQ/PQ protocols & reports  
  • Change control handling  
  • Deviation handling 

Excited to learn from our experts? Check out our upcoming course offerings, here.