PPT-1 FDA’s BIMO Inspection Program

and IRB Inspections VA IRB Chairs Meeting August 2012 Janet Donnelly RAC CIP Office of Good Clinical Practice Office of the Commissioner Food and Drug Administration 2 2 Disclaimer The views expressed in this presentation are those of the speaker and is consistent with 21 CFR 1085 k and constitutes an informal communication that represents the presenters best judgment at this time but does not constitute an advisory opinion does not necessarily represent the formal position of FDA and does not bind or otherwise obligate or commit the agency to the views expressed . 10 15 20 3 brPage 5br USDCNOAASeafood Inspection Program EFECT SUBFACTORS ETHOD OF DETERMINING SUBFACTOR SCORE EDUCTION POINTS Improper packing Moderate defects noticeably affecting he products appearance Excessive defects seriously FDA Requirements. Must comply with same US laws and regulations as domestic foods. GMPs. HACCP. Labeling. errors account for > 22% of detentions. Low acid canned foods. Importer must have:. food canning establishment registration on file with FDA. Introduction. Agenda Item 9D. Presented by:. Preston Shopbell, PE. Central Valley Flood Protection Board . March 23, 2018. Background. The 2017-18 Budget provided an increase of $2.2M to better accomplish our statutory responsibilities. Supplier Introduction. STEP. Q. SQA. Services. Program Scope & Overview. SpaceX . has commissioned SQA . Services, (SQA), to . provide . source inspection services at SpaceX’s supplier base throughout the US.. SAF/IGI. Office of The Inspector General. 24 June 2013. OVERALL BRIEFING CLASSIFICATION:. UNCLASSIFIED. Readiness Inspection. Readiness. Compliance Inspection. Readiness. Alignment with CSAF’s . Top 2 Priorities. . Kathy Gilmartin, MSN, CRNP, CCRC. Manager of Clinical Trials Quality Assurance. Background. FDA inspections are typically conducted at clinical sites to determine compliance with federal regulations and adherence to guidelines, to verify the . SHEDDING LIGHT ON AN FDA VISIT Joyce Nancarrow Tull, MSN, RN, CCRP University of Southern California USC Norris Comprehensive Cancer Center Clinical Investigations Support Office DISCLOSURES I have no financial disclosures precision.fda.gov | precisionFDA@fda.hhs.gov | @precisionFDA. Taha A. Kass-Hout, MD, MS. FDA Chief Health Informatics . Officer. Director, FDA’s Office of Health . Informatics. David . Litwack. , PhD. 106 1FDA Bioresearch Monitoring BIMO ChecklistRegulationDocuments Neededone copy for FDA auditor and one copy for logging Actions or Questions Which May Be AskedCompleteInitialsUpon notification of FDA au Daniel R LevinsonInspector General The mission of the Office of Inspector General OIG as mandated by Public Law 95-452 as amended is to protect the integrity of the Department of HealHHS programs as w to request assistance Our Office of Information Management and Technology OIMT will work with your firm to set up secure communicationsPlease notify the investigator of any delays due to this encrypti Jeff Shuren, MD, JD. Center for Devices and Radiological Health. U.S. Food and Drug Administration. www.fda.gov. Who We Are…. CDRH is a team of over 1,700 dedicated, highly-skilled people, including:. Associate Director. Quality Improvement Office. Office of Research Compliance. Federal Agency Audit. Conducted by FDA, Office of Human Research Protections, Office of Research Oversight, etc. . FDA most commonly performs Routine Inspections as part of the approval process for drugs or devices but can also audit For Cause..