/ http://www.slideshare.net/images/logo.gif / ºÝºÝߣShare feed for ºÝºÝߣshows by User: bonlam56 https://public.slidesharecdn.com/v2/images/profile-picture.png Professional Summary: GxP professional with experience, formal education and training in: • Conducting GxP audits to ensure compliance with global regulations and current industry expectations • Working with staff to develop, implement, track, and closeout Corrective and Preventive Actions in a timely manner. • Preparing and overseeing FDA, OHRP and IRB submissions to support the development and regulatory approval of new drugs, biologics and medical devices. • Interpreting global regulations and guidelines pertaining to GCP, GLPs, GMPs • Authoring and implementing site-wide SOPs to ensure compliance with GxP regulations • Developing and delivering training on GCPs, GMPs and