Data Acceptance Panel Discussion

Transcription

1 OFFICE OF FOODS AND VETERINARY MEDICINE Data Acceptance Panel Discussion January 31, th Governmental Food and Feed Laboratory Accreditation Meeting

2 The FDA Foods Veterinary Medicine Program and Office of Regulatory Affairs FOOD AND DRUG ADMINISTRATION OFFICE OF COMMISSIONER Office of Chief Council Office of Chief Scientist Office of Foods and Veterinary Medicine (OFVM) Office of Global Regulatory Operations and Policy OIP CVM CFSAN ORA Food & Feed NCTR 2

3 FSMA and the Laboratories F S M A Riskinformed, Prevention, Public Health Impact Building Strong Science Infrastructure Leveraging Resources Establishing Partnerships Increasing High-risked Compliance FDA Science & Research FDA Regulatory Compliance FDA Lab Requirements & ISO Standards State, Federal, International Regulatory Partners Industry, Domestic/ International FSMA Rules & Requirements FDA Labs State, Federal, Foreign Government Labs Private Independent Labs 3

4 FDA Foods Veterinary Medicine Program Strategic Plan FY CVM CFSAN OFVM ORA FVM Science and Research Key Initiatives A Frame Work for Aligning Science and Research Activities with the FVM Strategic Plan The Science Research Steering Committee (SRSC) is charged with providing oversight to all FVM researchrelated activities. The SRSC s role is to lead, coordinate and unify natural science search and method development strategies. Key components of the mission include: Developing and implementing an FVM science and research action plan, with Key Initiatives designed to strengthen and maintain core science and research capabilities Developing and implementing a common framework and process for prioritizing FVM research Developing and implementing a unified analytical methods development and validation program that is aligned with FVM priorities Developing and communicating improved processes for technology transfer of research and methods to FVM program offices Aligning the roles and responsibilities of each laboratory operating unit across FVM Optimizing use of laboratory staff and resources across FVM Verification Implementation Development Technology Exploration Validation (SLV, MLV) Modification Matrix Extension Platform Extension 4

5 The FDA Foods Veterinary Medicine (FVM) Science and Research Enterprise FOOD AND DRUG ADMINISTRATION OFFICE OF COMMISSIONER Office of Foods and Veterinary Medicine (OFVM) Science and Research Steering Committee Office of Chief Council Office of Global Regulatory Operations and Policy OIP Office of Chief Scientist CVM CFSAN ORA Food & Feed NCTR 5

6 MRCG Microbiology Research Coordination Group SRSC Science and Research Steering Committee CRCG Chemistry Research Coordination Group SCCG Science Compliance Coordination Group Outbreak Investigation Analytical s Compliance & Enforcement MMVS Microbiology s Validation Subcommittee TAGs Technical Advisory Groups CMVS Chemistry s Validation Subcommittee Inspection & Surveillance Prioritization Development Validation, Cross-center Collaboration method Implementation 6

7 FOODS AND VETERINARY MEDICINE S METHODS DEVELOPMENT, VALIDATION and IMPLEMENTATION PROGRAM (MDVIP) DOC #: OFVM-PM.001 v1.0 EFFECTIVE DATE: 10/10/2017 Development & Technology Evaluation Single Lab Validation (SLV) Multi Lab Validation (MLV) Implementation EMERGENCY USE ONLY MLV Proposal SLV Report MVS Approved & RCG CONCURRENCE? END NO SUBMISSION Development or Technology Evaluation Proposal* (PI APPLICANT) APPROVAL BY LOCAL MANAGEMENT FVM RESEARCH PRIORITIES MET? CARTS NO TAG RECOMMENDATION, MVS APPROVED, & RCG CONCURRENCE? LOCAL MANAGEMENT APPROVED? MLV PROPOSAL PREPARATION &/OR SLV REPORT NO WITH COMMENTS NO WITH COMMENT CARTS COMPLETION MLV REPORT FDA METHODS COMPENDIUM STANDARD METHOD COMMUNICATION PUBLISHED U.S. FDA REFERENCE METHODS SCCG MDVIP Process METHOD DEVELOPMENT OR TECHNOLOGY EVALUATION (PI) *Single lab validation in milestone MVS Validation Subcommittee RCG Research Coordination Group SCCG Science Compliance Coordination Group CARTS COMPLETED SLV STUDY RESOURCES: OFVM MDVI Program Chemistry MDVIP Guidelines Microbiology MDVIP Guidelines PI; Guidance provided by TAG/MVS (Consult Validation Guidelines) CARTS MLV STUDY RESOURCES: OFVM MDVI Program Chemistry MDVIP Guidelines Microbiology MDVIP Guidelines ORA/ORS IMPLEMENTATION IMPLEMENTATION Blue texts are hyperlinks CLICK HERE TO PRINT 7

8 FDA Compendium of Analytical Laboratory s for Food and Feed Safety List of methods & link to the BAM 8

9 Thank you! 9