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Minimize the Risk of Recalls - The Cost of Poor Pharmaceutical Packaging Management


Date: February 18, 2016

Featured Speakers:
  • Mike Baird, Global Business Development - Pharma & Life Sciences, Esko
  • Arpad Lehoczki, Senior Account Executive, Global Vision

The number of pharmaceutical product recalls is growing. Some estimates show that over 50% of recalls are related to pharmaceutical packaging artwork and labeling, with over 60% of those caused by human error. When these errors in pharmaceutical packaging result in recalls, the consequences are severe and include:

  • Risks to patient safety
  • FDA (and other regulatory agency) compliance issues
  • Cost/logistic problems through the supply chains
  • Fines
  • Reputation damages (brand and/or company)

Maintaining Good Manufacturing Practices (GMPs) for pharmaceutical packaging and labeling compliance is therefore critically important, and must follow regulations set out by the FDA governing electronic systems, known as 21 CFR Part 11, and by the European Commission Annex 11 guidelines.

To tackle these issues, many companies have used a fail-safe approach by integrating:

  • 1. Pharmaceutical packaging and labeling management software dedicated to GMP labeling and packaging artwork change management
  • 2. Digital packaging quality control tools designed to stop pharmaceutical packaging and labeling errors by accurately inspecting barcodes, braille, artwork text and spelling

In this webinar, the audience will learn how to reduce recalls from pharmaceutical packaging errors using these methods. The speakers will discuss examples, implementation, features and benefits of this integrated approach.

Keywords: Pharmaceutical Packaging, Good Manufacturing Practices


    Mike Baird, Esko

    Mike Baird, Global Business Development - Pharma & Life Sciences, Esko

    Mike is an experienced strategic business manager with more than 20 years in packaging, pre-media and print. The past 8 years he specialized in the pharmaceutical and life sciences verticals. Mike is currently charged with creating and executing Esko's Pharma and life sciences go-to-market strategy on a global scale.

    Arpad Lehoczki, Global Vision

    Arpad Lehoczki, Senior Account Executive, Global Vision

    Arpad Lehoczki is a Senior Account Executive at Global Vision Inc. For the past 17 years, Arpad has worked closely with Fortune 500 companies within the consumer goods, pharmaceutical, printing and agricultural industries to help them improve their quality control and workflow processes. He is an industry expert on proofreading / quality control technologies, and understands the unique needs facing customers looking to ensure brand integrity in today's market.


    C-level and Senior Level executives from biopharma companies working within:

    • Quality Control/ Quality Assurance
    • Regulatory Compliance
    • Graphics
    • Packaging


    Esko is the worldwide market leader providing software for workflow automation, quality assurance and online collaboration. Esko’s packaging and labeling management solution helps pharmaceutical and life sciences companies manage their packaging preproduction specifications, regulatory content and artwork portfolio in a compliant and secure way, helping raise productivity, reduce time-to-market, lower costs, expand business and improve profitability.

    Key features:

    • Developed to GAMP5 guidelines
    • Fully validatable
    • FDA 21 CFR Part 11 compliance controls built in
    • Developed to cGMP guideline standards
    • Full audit trail and version control
    • Barcode and Braille checking functionality via Global Vision integration

    Benefits for life sciences and pharma companies:

    • Build quality into your process
    • Reduce risk of errors at every stage
    • Maintain absolute control and compliance
    • Manage the challenges of controlling your packaging and labeling copy and content
    • Adapt to changing regulatory requirements with ease

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