Team · Risk Assessment and GMP Documentation
Leidy Fajardo
Risk Assessment and GMP Documentation
Key areas
What Leidy is responsible for at A&O.
Leidy Fajardo is responsible for risk assessment and GMP documentation. She holds a bachelor's degree in pharmaceutical chemistry, a master's degree in biomedical informatics and a specialisation in strategic management. At A&O Pharma, she works on document preparation, operational QM support and strategic GxP consulting. Her combination of pharmaceutical chemistry and data science is particularly valuable for formal risk assessments.
- Risk assessment
- GMP documentation
- Data science
Education
B.Sc. Pharmaceutical Chemistry, M.Sc. Biomedical Informatics, specialisation in strategic corporate management
Responsible for 3 services
Case studies
Case studies from Leidy's areas of work.
Anonymised projects from the services Leidy is responsible for.
Clinical trial sponsor, small biotech company
From IMPD to QP release, all from a single provider
A new active substance from a non-EU country was to be used in a phase 1 trial as an investigational medicinal product. We provided GMP oversight, pro...
Read the full case studyInnovative biotech company in cancer therapeutics
Setting up a GMP manufacturing facility for peptide vaccines
A research institution is setting up a GMP manufacturing facility for personalised peptide vaccines. We are supporting it from regulatory classificati...
Read the full case studyThe whole company
