Pharmaceutical packaging and labeling is designed to serve 2 main purposes: protection and communication. It exists to protect the medication from outside influences that could cause contamination, for example, but it is also there to protect the patient and/or dispensing healthcare professional from harm. Additionally, the packaging needs to communicate to both the dispensing healthcare professional AND the patient, including detailed information that must be accurate, simple to understand and not open to misinterpretation. This information, along with the specifications of the packaging itself, comes from multiple sources and involves many touch points throughout the supply chain, both externally and internally.
In addition, pharmaceutical and life science companies are under mounting pressure to comply with ever-changing regulations and increasing market pressures whilst maintaining a commercially viable and robust portfolio. Add to that internal organizational expectations, competition from other manufacturers and niche markets and product expansion, and it’s not hard to understand how complexity can creep in to the packaging and labeling portfolio. This complexity can come in many forms such as a greater number of assets per product and SKU, interaction with multiple suppliers throughout the supply chain and managing constant changes in regulations.
Companies need to not only be aware of this challenge but more importantly, they need to ensure that they have controls in place to manage these issues, limiting further complexities arising AND reducing the potential consequences in the future.
In this webinar, the presenter will show how pharmaceutical packaging and labeling complexity occurs, what the consequences are of inaction, and most importantly, what pharmaceutical companies can do to reduce and manage the process.
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.
Who Should Attend?
C-level and Senior Level executives from biopharma companies working within:
- Quality Control/ Quality Assurance
- Regulatory Compliance
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.
– 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