Training Update: Preventive Controls Regulator Training
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1 Training Update: Preventive Controls Regulator Training Patricia L. Alcock Director, Office of Training, Education and Development Food and Drug Administration 1/30/2018 9:00 AM
2 Today s Agenda - Preventive Controls for Human Food Training - Future Training Considerations
3 Preventive Controls for Human Food Regulators Training Course FD254
4 OVERVIEW/TOPICS Course Description Course Goal/Objectives Course Outline Class Schedule for FY18 Reference: PC CAP Webinar, 12/13/2017
5 FD254 Course Description Learn how to apply a systematic approach to inspect food manufacturing firms based on the Current GMP, Hazard Analysis and Risk- Based Preventive Control Regulation, and to document violations of this regulation observed during the inspection.
6 FD254 Course Description Introduces Current GMP, Hazard Analysis and Risk-Based Preventive Controls (GMP/PC). GMP/PC provides an overview of the regulatory requirements for food facilities and how to apply them during an inspection. Participants complete mock scenarios perform a final assessment to reinforce their understanding through application of the course material.
7 FD254 Objectives 1. Describe the guiding principles for systemsbased inspection process. 2. Interpret 21 CFR Determine the scope of the inspection by asking open-ended questions to verify establishment type and to identify product for coverage. 4. Gather information for hazard analysis through interview and observation.
8 FD254 Objectives 5. Conduct a hazard analysis based on information gathered. 6. Evaluate components of the food safety plan for adequacy. 7. Using observation skills and interviewing techniques, formulate open-ended questions to determine if a facility is implementing their food safety plan.
9 FD254 Objectives 8. Provide the basis for reporting observation of non-compliance of the preventive controls for human foods regulation. 9. Review a firm s Food Safety Plan to determine compliance with the PC rule.
10 FD254 Course Prerequisites ORA s New Hire Investigator Training Program or equivalent Level 1 Investigator Certification or equivalent (ORA Staff) Successfully Completed FD180 (OR both FD150 & FD151) Watch FD8000 webinar on Modernized GMPs (live or recorded) (available via ORA OTED LMS) Successfully Complete FSPCA Human Food Training Successfully Complete the FD254W100 online course
11 Introduction to PC for Human Foods Web Course FD254W100* Online Module 1: Course Overview Online Module 2: Modernized Good Manufacturing Practices (GMPs) Online Module 3: Modernized Good Manufacturing Practices (GMPs) Online Module 4: Subparts D&E Modified Requirements & Withdrawal of Qualified Facility Exemption Online Module 5: Subpart F: Requirements Applying to Records That Must be Established & Maintained Online Module 6: Subpart G Supply-Chain Program Online Module 7: Training Requirements Online Module 8: Microbiological Controls for LACF & Acidified Foods *Must be completed before take FD254
12 FD254 Classroom Course Outline Introduction: Systems Thinking Module 1: Intro to 21 CFR 117 Module 2: Initial Interview Module 3: Gathering Information for your Hazard Analysis
13 FD254 Classroom Course Outline Module 4: Modified Requirements & Withdrawal of Qualified Facility Exemption Module 5: Requirements Applying to Records That Must be Established and Maintained
14 FD254 Classroom Course Outline Module 6: Evaluating the Adequacy of the Food Safety Plan Module 7: Assess Food Safety Plan Implementation Module 8: Document Inspection Observations Final Assessment: Application of all Modules
15 FD254 FY18 Course Schedule
16 FY18 CLASS SCHEDULE States will receive at minimum 40% course slots. OTED/OP has prioritized attendance of those states already committed to complete the work. OTED/OP followed established procedure for slot allocations amongst the remaining state in collaboration with ORA s Office of Partnership and the Pre-Registration Workbook.
17 FY19 CLASS SCHEDULE Need to understand the needs of States and their inspection staff. AFDO Data call will be used to help determine number of needed slots per FY19 and FY20.
18 Future Training Considerations Training WG on Alternative Options Develop proposals to address: Equivalency Tools Training Course Individuals FDA Course Training Hand Off Same course content Qualified Instructors Train the Trainer Programs
19 Future Training Considerations Training WG on Alternative Options Next Steps? Develop and finalize recommendations ORA & FDA Review recommendations Socialize recommendations PFP, CFP, AFDO, AAFCO, NASDA Determine interest by State Ag and Health Impact of scaling up pilot programs Develop Implementation and Communication Plan
20 Future Training Considerations Train the Trainer Programs Interest by States? Availability of State personnel? Process/Procedures Requirements for Consistency Where can AFDO or MFRP Alliance assist?
21 Future Training Considerations FDA/ORA Training Needs Survey FY19 & Beyond MFRPA & One time funding for FD152 Collaboration with academia IFSS National Curriculum Standard Where can AFDO or MFRP Alliance assist?
22 Contact Information Patricia L. Alcock Director, Office of Training, Education and Development FDA/Office of Regulatory Affairs
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This document is scheduled to be published in the Federal Register on 01/26/2018 and available online at https://federalregister.gov/d/2018-01276, and on FDsys.gov Billing Code 4210-67 DEPARTMENT OF HOUSING