2017 Governmental Food and Feed Laboratory
​Accreditation Meeting

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Please note: not all presentations are available for posting

Tuesday, January 24, 2017

8:15 am - 9:00 am

FSMA, IFSS, and Public Health 

• Barbara Cassens, Director, Office of Partnerships, U.S. Food and Drug Administration 
• Tim McGrath, Deputy Office Director for Food and Feed, ORS, U.S. Food and Drug Administration 

9:00 am - 10:15 am​

Laboratory Data Sharing, Acceptance and Mutual Reliance

• Kathryn Wangsness, Chief/QA Manager, Arizona Department of Health Services – Best Practices for Submission of Actionable Food and Feed Testing Data Generated in State and Local Laboratories 
• Palmer Orlandi, Chief Science Officer and Research Director (acting), CFVM, U.S. Food and Drug Administration - Data Acceptance and Mutual Reliance on State and Federal Laboratory Data for Public Health Decisions
• Terri McConnell, ORS, U.S. Food and Drug Administration - FDA Laboratory Data Review Process
• Solomon Tadele, Senior Regulatory Research Officer, U.S. Food and Drug Administration – Promoting the use of ELEXNET for Data Sharing and Public Health Decisions​

10:45 am - 11:15 am​

Partnership for Food Protection IT Workgroup Information Sharing

• Lisa Creason, Director, Information Systems Management, ORA, U.S. Food and Drug Administration
• Matt Colson, Environmental Administrator, Florida Department of Agriculture and Consumer Services

​11:15 am - 12:00 pm

Lab/Program Success Stories - Case Studies Demonstrating Successful Collaboration and Innovative Approaches 

• Lisa Ramsey, Regional Manager, Food Safety Program, Virginia Department of Agriculture and Consumer Services - VDACS  Sample Module
• Maria Ishida, Laboratory Director, New York Department of Agriculture and Markets – New York Mutual Reliance Pilot
• Ben Miller, MFRPA Vice-Chair, Division Director, Minnesota Department of Agriculture – Minnesota  GOODSamples Pilot Project

1:30 pm - 3:15 pm

Town Hall Session with FDA, Labs, and MFRPA 

• Moderator: Mark Reed, AFDO, Program Manage
• Pat Alcock, Director, DHRD, U.S. Food and Drug Administration
• Barbara Cassens, Director, OP, U.S. Food and Drug Administration
• Joann Givens, Acting Regional Food and Drug Director, U.S. Food and Drug Administration
• Glenda Lewis, Director, Retail Food Protection Staff, CFSAN, U.S. Food and Drug Administration
• Dr. Paul Norris, Director, ORS, ORA, U.S. Food and Drug Administration 
• Michael Rogers, Senior Advisor, U.S. Food and Drug Administration

Measurement of Uncertainty Workshop for Food and Feed Laboratories: A Practical User Friendly Approach 

• Moderator: Dirk Shoemaker, SME, Association of Food and Drug Officials
• Heidi Hickes, Bureau Chief, Analytical Laboratory Bureau, Montana Department of Agriculture
  • Handout 1
  • Handout 2
• Susan Humphries, M.S., CMQ/OE, Microbiologist – Acting Quality System Manager, Office of Regulatory     Affairs, Pacific Regional Laboratory Northwest, U.S. Food and Drug Administration
• Patricia Hanson, Biological Administrator I-Microbiology Supervisor, Bureau of Food Laboratories, Florida     Department of Agriculture and Consumer Services

3:45 pm - 5:00 pm

Root Cause Analysis

• Moderator: Dirk Shoemaker, SME, Association of Food and Drug Officials
• Roger Brauninger, Program Manager, Biosafety, A2LA 

Internal Audits—Who Does Them and How? 

• Moderator: Heidi Hickes, Bureau Chief, Montana Department of Agriculture
•  “Internal Auditor Training"
  • ​ Marcia Valbracht, MHA, Manager, Quality Systems, State Hygienic Laboratory at the University of Iowa
• "iAuditor for Internal Auditing: Georgia Department of Agriculture approach to Internal Audits”
  • Ian McCarron, Laboratory Scientist II, Georgia State Department of Agriculture
    • Georgia Dept. of Agriculture Internal Audit Checklist – Procedures   
• “How to Perform Internal Audit"
  • ​Cynthia M. Mangione, Food Laboratory Specialist 2 – Microbiology QAO, New York State Department of Agriculture and Markets | Food Laboratory Division
  • Renee Rice, PhD, Quality System Manager, Detroit Laboratory, FDA, ORA, Office of Regulatory Science
    • On-site Review Form
    • Sample Accountability Form 
    • Analytical Worksheet Review Form
  • Patricia Hanson, Biological Administrator I-Microbiology Supervisor, Bureau of Food Laboratories, Florida Department of Agriculture and Consumer Services

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Wednesday, January 25, 2017

8:00 am - 9:00 am

Laboratory General Session 

• Moderator: Kathryn Wangsness, Chief, Office of Laboratory Services, Arizona State Public Health Laboratory

Cracking the ISO CAP Code 

• Ruiqing Pamboukian, Ph.D., Commander, U.S. Public Health Service, FDA, ORA, Office of Regulatory Science

Standard 10 Revision and Scopes of Accreditation

• Guy F. Delius, R.S., CSO-MFRPS Specialist, Office of Regulatory Affairs, Office of Partnerships, U.S. Food and Drug Administration

Future Funding Model for the Laboratory 

• Barbara Cassens, Director, Office of Partnerships, Office of Regulatory Affairs, U.S. Food and Drug Administration   

9:00 am - 9:45 am​

A CFSAN Update on Laboratory Operations ​​

• Moderator: Kathryn Wangsness, Chief, Office of Laboratory Services, Arizona State Public Health Laboratory
• Steven Musser, Ph.D.,  Deputy Director, Center Director for Scientific Operations, CFSAN, U.S. Food and Drug Administration 

10:15 am - 12:00 pm​

Method Validation and Verification 

• Moderator: Cynthia Mangione, Microbiology QA Officer, New York State Department of Agriculture and Markets
• Michael Brodsky, President, Brodsky Consultants

1:30 pm - 3:00 pm

FDA's Electronic Laboratory Exchange Network (eLEXNET)

• Moderator: Heidi Hickes, Bureau Chief, Montana Department of Agriculture
• Vanessa Holley, MPH, Manager, Informatics Policy and Member Outreach, Association of Public Health     Laboratories
• CDR Mivoyel Jeanpaul, Director, Laboratory Operations and Support Staff, FDA\ORA\OO\ORS\LOSS
• Linda Paige, Consultant, Paige Consulting Services
• LCDR Solomon Tadele, Business Program Manager, FDA\ORA\OO\ORS\LOSS

3:30 pm - 5:00 pm​

In Depth Review of the Data Acceptance White Paper

• Moderator: Dirk Shoemaker, SME, Association of Food and Drug Officials
• Facilitator: Ruiqing Pamboukian, Ph.D., Commander, U.S. Public Health Service FDA, ORA, Office of Regulatory Science

FDA process

• Terri McConnell, Commander, U.S. Public Health Service FDA, ORA, Office of Regulatory Science

Data acceptance white paper

• Kathryn Wangsness, Chief/QA Manager, Arizona Department of Health Services

Chain of custody

• Terri McConnell, Commander, U.S. Public Health Service FDA, ORA, Office of Regulatory Science
• Kathryn Wangsness, Chief/QA Manager, Arizona Department of Health Services

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Thursday, January 26, 2017

8:00 am - 8:30 am

Strategic Coordinated Oversight of Recall Execution (SCORE) Presentation

• Joann Givens, Acting Regional Food & Drug Director, U.S. Food and Drug Administration​

8:30 am - 9:30 am

Achievement of the States and 2016 Preparation/Review

• Ellen Buchanan, Director, Audit Staff, Office of Operations, U.S. Food and Drug Administration
• Ruiqing Pamboukian, Regulatory Scientist, U.S. Food and Drug Administration
• Timothy Weigner, Director, Standards Implementation Staff, OP, U.S. Food and Drug Administration

9:30 am - 10:00 am

Strategic Plan and Looking Forward to the Next Five Years 

• Barbara Cassens, Director, Office of Partnerships, U.S. Food and Drug Administration

10:45 am - 11:30 am

What to Expect Over the Next Five Years: State Perspective Organizational Change

• Ben Miller, MFRPA Vice-Chair, and Division Director, Minnesota Department of Agriculture

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