Amnon Eylath is Director of Quality at Ariad in Cambridge, Massachusetts. He is responsible for global oversight of the QA/QC aspects of Drug Substance and Drug Product Manufacturing, Testing, Stability, Packaging and Distribution, as well as oversight of compliance for Pre-Clinical (GLP) and Clinical (GCP) Studies. Amnon has over 20 years of experience in medical research, process & method development, device development, facility/process design and validation, GxP audits and regulatory compliance, CMC support, development and deployment of quality systems, as well as disposition of Biotech and Small Molecule clinical materials for US and international use.
Amnon is currently is leading the development of a technical report on the application of cGMP and Quality Systems for the complete development life-cycle of Biotech Drug Substance, in collaboration with industry and regulatory agency representatives. He is also a core member of industry Task Forces developing technical reports for application of GMPs to Investigational Medicinal Product, Development of Specifications for Early Phase drug development and Risk-Based auditing. He has recently commented to changes in Eudralex regulations covering drug development. He has also lectured at Moorpark College, UC Davis and Indiana University on Quality and Pharmaceutical Technology subjects, and was instrumental in the establishment of the Biotechnology certification and degree programs (respectively) at Moorpark College and Indiana University.
An overview of the drug development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. Recorded
Ensuring GCP quality has often been approached from the perspective of reviewing as many documents as possible, looking for errors and following up on corrections or making "notes to file." In order to design, implement, and maintain GCP compliance in an effective manner, a Quality Systems Approach should be adopted. Recorded
In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and knowledge to the levels required for an approvable launch. Recorded