Description
Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and PMA application with their review and approval processes, QSR for medical devices, CAPA. Brief understanding of FDA regulations on drugs and biologics requirements. Projects and Seminars Presented a research project on Regulatory Approval for Class III device in United States. Presented a research project on Drug Registration process in Latin American Countries and Risk Management ISO 14971.
