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“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”   
                                               
Institute of Medicine of the National Academies

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Planning Sessions

Under the direction of senior executives, a hand picked team of our experts with experience that is matched to your specific business needs, will work exclusively with your executive leadership team to develop a new strategy or to assess your current Integrated Packaging Management strategies.

The planning session results in an executive overview of current packaging systems, desired functionality, recommendations for labeling software, hardware (if any) or hybrid solution, a solution architecture with connectivity and interfaces to current systems, flow diagram and work flow, component identification and recommendations, a fixed investment and time table for the complete implementation, and in some cases an ROI analysis.

Planning Session Highlights

Executive assessment of Integrated Packaging Management
  • Industry, market and competitive analysis
  • Current state-of-the-business (as is)
  • Business plan/strategy evaluation
  • Executive briefing and coaching
Executive strategy development for Integrated Packaging Management initiative
  • Mission and vision development
  • Objectives, strategies and tactics development
  • Organizational and business alignment planning
  • Risk assessment and contingency development
  • Financial modeling and ROI analysis
  • Implementation and deployment
  • Support and maintenance planning
  • Validation and audit strategy
Forecasting and budgeting for the global initiative
  • Resource assessment and requirements
  • Sensitivity analysis
  • Cost justification and financing analysis
  • Projections and Pro Forma's
Measurement
  • Success criteria definition
  • Metrics definition and evaluation process
  • Adjustment process definition and methodology

Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI

 

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