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.

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  • 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.

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