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 Presented to . SCRA. By Jim Stanley. Two challenges. The ongoing challenge to insure the safety of the workforce.. The new challenge of greatly increased OSHA enforcement.. Two challenges. Dealing with the second challenge doesn’t always help insure success with the first.. 1. NRP Overview – Past, Present, & Future. 2. Food Safety and Inspection Service:. NRP Overview. Food Safety and Inspection Service:. NRP Overview. 3. Scheduled Sampling Program. 4. Food Safety and Inspection Service:. UST Inspection Program. UST Inspector pre-inspection work and items checked during inspection. Operator training. Delivery prohibition. UST regulation revisions . Joe Stapinski, UST Inspector. (317) 727-6775. Mike deMasi. Chief Emergency Management,. PL 84-99 Program Manager. Galveston District . Scott Leimer. Levee Safety Program Manager. Galveston District . October 2014. Agenda. Policy and Process. Inspection Criteria. 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. Page of harethe draft planwith FDA a preNDA meetingor a similar form of communicationpdate and finalize the BIMO data planwith feedback from the FDA reviewersxecute the BIMO data plan Create eCTD docu 1Overview of Overview of Clinical Investigator CIClinical Investigator CIBioresearchMonitoring/ucm133789htmBioresearchMonitoring/ucm133789htmSponsor Contract Research Organizations and Sponsor Contrac 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 n and Research or CBER conducting clinical research are also referred to as Good Clinical Practices or regulations for nonclinical laboratories compliance regulations during inspections sure that Programs and Services. SCI facilitates the efficient, fair marketing of America’s fresh, frozen, and processed fruits, vegetables, and other specialty crops by providing:. Grading, inspection, and certification services. Pre-Market Compliance and . Administrative Actions Team. (BIMO Team). Overview of CVM Bioresearch Monitoring. An Agency-wide inspectional process focused on data quality of safety and efficacy studies. These studies are submitted during the approval/review process for food and medical products regulated by FDA..