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DTSTART;TZID=America/New_York:20230511T154500
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UID:56995-1683819900-1683824400@globalbiodefense.com
SUMMARY:Collaborating on Culture in the New Era of Smarter Food Safety
DESCRIPTION:Live from the Food Safety Summit: Measure What You Treasure\nMay 11\, 2023\, from 3:45 pm 5:00 pm ET \nThe upcoming webinar will focus on the importance of assessing food safety culture in an organization. \nGuest speakers include: \n\nDonald A. Prater\, DVM\, Acting Director\, Office of Food Policy and Response\, FDA\nConrad Choiniere\, PhD\, Director\, Office of Analytics and Outreach\, Center for Food Safety and Applied Nutrition\, FDA\nLone Jespersen\, Principal and Founder\, Cultivate SA\nVanessa Coffman\, Director\, Alliance to Stop Foodborne Illness\nBrian Perry\, Executive Food Safety & Quality Leader\, TreeHouse Foods\, Inc\nKarleigh Bacon\, Director of U.S. Supply Chain Food Safety\, Science & Regulatory\, McDonald’s Corporation\nPhilip Bronstein\, Ph.D.\, Assistant Administrator\, Office of Field Operations\, Food Safety and Inspection Service\, Food Safety and Inspection Service\, USDA\n\nThe U.S. Food and Drug Administration and Stop Foodborne Illness\, a non-profit public health organization\, are collaborating on a webinar series that explores food safety culture\, one of the core elements in FDA’s New Era of Smarter Food Safety initiative. \nThe New Era of Smarter Food Safety blueprint states that dramatic improvements in reducing the burden of foodborne illness cannot be made without doing more to influence the beliefs\, attitudes\, and\, most importantly\, the behaviors of people and the actions of organizations. \nPlease visit the FDA’s Collaborating on Culture in the New Era of Smarter Food Safety event page for more information and to register to attend this virtual event.
URL:https://globalbiodefense.com/event/collaborating-on-culture-in-the-new-era-of-smarter-food-safety/
CATEGORIES:Government Hosted
LOCATION:https://zoom.us/webinar/register/WN_uMaG_U92TLGqb-2bTozXSw#/registration
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DTSTART;TZID=America/New_York:20230518T083000
DTEND;TZID=America/New_York:20230518T173000
DTSTAMP:20230421T194600Z
CREATED:20230421T194600Z
LAST-MODIFIED:20230421T194600Z
UID:56993-1684398600-1684431000@globalbiodefense.com
SUMMARY:VRBPAC Meeting on Pfizer's ABRYSVO Respiratory Syncytial Virus Vaccine
DESCRIPTION:Vaccines and Related Biological Products Advisory Committee May 18\, 2023 Meeting Announcement \nOn 18 May 2023\, the committee will meet in open session to discuss and make recommendations on the safety and effectiveness of ABRYSVO (Respiratory Syncytial Virus Vaccine)\, manufactured by Pfizer Inc.\, with a requested indication\, in Biologics License Application (BLA) 125768 (STN 125768/0)\, for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by RSV in infants from birth through 6 months of age by active immunization of pregnant individuals. \nAdvisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA\, which generally follows the recommendations but is not legally bound to do so. Please see\, “Advisory Committees Give FDA Critical Advice and the Public a Voice\,” for more information. \nMeeting Materials\nFDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting\, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Additional materials will be posted on FDA’s website after the meeting. \nMaterials for this meeting will be available at the Vaccines and Related Biological Products Advisory Committee meetings main page. \nThe meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting. \nPublic Participation Information\nInterested persons may present data\, information\, or views\, orally or in writing\, on issues pending before the committee. FDA is establishing a docket for public comment on this meeting. \nThe Docket Number is FDA-2023-N-1338 \nComments received on or before May 11\, 2023\, will be provided to the committee. Comments received after May 11\, 2023\, and by May 17\, 2023\, will be taken into consideration by FDA. In the event the meeting is canceled\, FDA will continue to evaluate any relevant applications or information\, and consider any comments submitted to the docket\, as appropriate. \nPlease visit the VRBPAC Meeting Announcement page for more information.
URL:https://globalbiodefense.com/event/vrbpac-meeting-on-pfizers-abrysvo-respiratory-syncytial-virus-vaccine/
CATEGORIES:Government Hosted
LOCATION:https://www.youtube.com/watch?v=NXVMILYvocM
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DTSTART;TZID=America/New_York:20230524T090000
DTEND;TZID=America/New_York:20230524T140000
DTSTAMP:20230421T193224Z
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UID:56991-1684918800-1684936800@globalbiodefense.com
SUMMARY:Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
DESCRIPTION:FDA CDER Office of Pharmaceutical Quality is offering a five-hour webinar to discuss reporting requirements and expectations for Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR). The statutory reporting requirements are found in 21 CFR 314.81 (for FAR) and 21 CFR 600.14 (for BPDR). FDA will share how it assesses these reports and how they support risk-based decisions in a variety of contexts. These reports provide an early warning signal to the agency that a marketed product may harm patients due to a deviation or incident that has occurred. \nThis webinar will present FDA expectations for conducting root cause analysis and then implementing and assessing effectiveness of corrective action and preventive action plans (CAPAs) to mitigate the severity and probability of harm. Attendees will learn how the agency is integrating advanced analytics (e.g.\, machine learning and natural language processing) to innovate processes and facilitate proactive approaches to quality risk management. FDA will also share some common reporting errors as well as best practices for report submission. \nTOPICS COVERED\n\nPost-market reporting (FARs and BPDRs) requirements and expectations – who is responsible for reporting\, how do you report\, and what happens if they are not reported\nFDA’s use of post-market quality defect reports to support risk-based decisions\nThe parameters of OPQ’s assessment for FARs and BPDRs (i.e.\, how are they assessed and what is the overall business process OPQ manages\nThe integration of advanced analytics into OPQ’s post-market quality defect report program\n\nLEARNING OBJECTIVES\n\nWhat are the post-market reporting requirements and expectations for application holders and manufacturers.\nHow does FDA manage and assess the reports.\nWhat to expect regarding follow-ups and engagement from FDA after submitting a report.\nHow does FDA utilize FARs/BPDRs to support regulatory decisions (e.g.\, surveillance inspection prioritization\, pre-approval/pre-license inspections\, regulatory flexibility\, etc.).\nHow does FDA integrate FARs/BPDRs into their overall assessment on the state of pharmaceutical quality.\nHow is FDA innovating processes for managing FARs/BPDRs with the integration of advanced analytics.\n\nINTENDED AUDIENCE\n\nNDA\, ANDA\, BLA applicant holders\nGeneric and New Drug Pharmaceutical manufacturers (including CDMOs)\nContract Testing Laboratories\nRegulatory Affairs professionals supporting post-marketing reporting requirements\nQuality Assurance and Quality Control professionals\nConsultants supporting pharmaceutical manufacturers\nForeign Regulators\n\nFDA RESOURCES\n\n21 CFR 314.81\n21 CFR 600.14\nField Alert Reports\nCDER – Biological Product Deviations\n\nCONTINUING EDUCATION\nReal-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. \nThis webinar has been: \n\npre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.\npre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations\, operations or management\, or to the candidate’s clinical research therapeutic area.\npre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration\napproved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.\n\nPlease visit the FDA’s Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR) meeting page for more information and to register to attend virtually.
URL:https://globalbiodefense.com/event/update-on-field-alert-reports-far-and-biological-product-deviation-reports-bpdr/
CATEGORIES:Government Hosted
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