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21 CFR Part 11 A Food Industry Perspective FDA Public Meeting June 11, 2004

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21 CFR Part 11 A Food Industry Perspective FDA Public Meeting June 11, 2004. Sia Economides Center Director Center for Development of Research Policy and New Technologies National Food Processors Association. National Food Processors Association (NFPA)

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Presentation Transcript
slide1

21 CFR Part 11

A Food Industry Perspective

FDA Public Meeting

June 11, 2004

Sia Economides

Center Director

Center for Development of Research Policy and New Technologies

National Food Processors Association

slide2
National Food Processors Association (NFPA)

Is the principle scientific and technical trade association representing the $500 billion dollar food processing industry on government and regulatory affairs, scientific research, technical assistance, education, communications and crisis management.

food industry perspective
Food Industry Perspective
  • Original Concerns:
    • Which electronic records need to comply?
    • What about legacy systems?
    • What do we need to validate?
  • With the new guidance document, primary concerns of e-records and legacy systems are addressed
  • What about validation?
validation
Validation
  • Existing Documents in Use by the Food Industry
    • FDA Guide to Inspections of Computerized Systems in the Food Processing Industry, 1998
    • NFPA Guideline: 43-L Bulletin – Validation Guidelines for Automated Control of Food Processing Systems (based on GAMP)
risk analysis approach
Risk Analysis Approach

NFPA Members agree with the risk-based approach to compliance

risk analysis approach in the food industry
Risk Analysis Approach inthe Food Industry

Currently:

  • FDA Food Regulatory Requirements are risk based
  • HACCP based on risk analysis
  • Risk Assessment tools for RTE refrigerated products

Focus of the Risk Analysis is on Public Health

recommendations
Recommendations
  • Given that:
  • §11.1 and 11.2 are addressed in recent guidance
  • §11.3 is addressed in existing guidance and technical documents
  • §11.10, 11.30, 11.50, 11.70 are addressed in existing guidance documents and predicate rules

What’s left that cannot be addressed in guidance?

recommendations8
Recommendations
  • We recommend:
    • Rescinding the regulation
    • Addressing the additional requirements through guidance
    • Focus on defining the intent – Let Industry identify how to comply
  • Provides for:
    • Specificity to industry segments
    • Getting away from “one size fits all”
    • New Technology to be implemented