Our QA staff participates directly in client and FDA inspections, in order to update their knowledge of industry trends, inspection strategies, and current EMA guidelines. QA staff also attends external formal training in current regulatory topics to further broaden their knowledge base.
Alison King (BSc (Hons), PhD) is the Director of Quality Assurance for GLP (Bioanalysis) and GCP (Clinical Trials). She received post-doctoral training at Penn State University and Texas Tech University and joined DynaKin in 2011 as a clinical research auditor and quality assurance technician. Her responsibilities include the planning and conduct of general, process and study specific inspections and the audit of protocols, study plans, clinical study reports, final reports, computerised systems and other study documentation and data. Alison is responsible for organising and developing internal training courses to ensure proper GCP knowledge of laboratory staff and when required performing audit of the clinical trial to evaluate trial conduct and compliance with the protocol, SOPs, GCP and applicable regulatory requirements. She has an in-depth knowledge of GLP/GCP regulations and has successfully participated in GLP/GCP and client audits.
Susana Serrano is Quality Assurance Technician for GLP (Bioanalysis). She is Degree in Pedagogy and specialized in quality management. Her responsibilities include the conduct of general, process and study specific inspections and data revision. She has more than seven years´ experience in Dynakin at the Quality Assurance Unit Department.
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