Insights into FDA CFR 11 and packaging

The following insights were delivered by 3M’s Mike Haldane, during his presentation, FDA CFR 11 and Packaging, at a conference session at Pack Expo International, held in Chicago in November.

Pw 12196 7 Nl Pi Jb 3m

  • Approximately 50% of all recalls are due to packaging errors.

  • Consumer safety cannot be compromised by mislabeled products, including usage instructions, allergen warnings, and ingredient statements.

  • Life science companies cannot afford to compromise quality, in packaging or anything else.

  • Information Technology systems that are document-based do not address critical packaging issues in life sciences.

  • Integrated packaging management provides needed functionality to ensure top quality.

    Haldane said, “Many pharmaceutical companies have over-the-counter products, too.” He explained that consumer packaged goods companies have distinct packaging needs that if addressed can produce significant results, including:

  • Increasing speed to market

  • Reducing packaging costs

  • Enforcing brand standards.

  • Complying with retailer mandates.

    Click here for a direct PDF format download of Haldane’s presentation. Click here for a list of all available presentations.

  • Don't miss Packaging Recycling Summit 2026
    Where innovation meets sustainability. Join the leading forum for packaging recycling professionals, featuring cutting-edge solutions, expert insights, and the connections you need to advance the circular economy. Secure your spot today.
    Discover More
    Don't miss Packaging Recycling Summit 2026
    Need help with your packaging project?
    We’ve done the legwork to identify and vet experienced packaging and processing consultants you can contact directly for your next project. Decades of combined experience in packaging line engineering, machinery selection, package and materials development, and food processing operations.
    See your advisor options now.
    Need help with your packaging project?