Team · Risk Assessment and GMP Documentation
Leidy Fajardo
Risk Assessment and GMP Documentation
Key areas
What Leidy stands for.
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 corporate management. At A&O Pharma, she works on document preparation, operational QM support and strategic GxP consulting. Her combination of pharmacy and data science is particularly valuable for formalised 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.
Anonymised projects from the services for which Leidy is responsible.
Sponsor of clinical trials, small biotech company
From the IMPD to release, all from a single source
Active substance manufacture in a non-EU country, formulation development, analytics and QP release: a project combining almost all of our services.
Read the full case studyInnovative biotech company in the field of cancer therapeutics
Establishing a GMP manufacturing facility for peptide vaccines
A renowned research institution is setting up a manufacturing facility for personalised peptide vaccines, we support them from regulatory affairs thro...
Read the full case studyThe whole company
