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Six Sigma, Lean, & Remedial Project Management

Six Sigma & Lean Project Management Services

  • Lean Process Evaluation & Assessment and Variation Identification
  • Strategic Planning
  • Continual Improvement Opportunity Identification
  • Metric Identification and Tracking, Progress Reporting
  • Problem Investigation
  • Program Tool Design and Development
  • Training
  • Professional and Technical Skill Set Development
  • Leadership Communication and Mentoring

 

Remedial Project Management Services

  • Remedial Action Plans
  • Warning Letter and Consent Decree Management
  • Response to Findings Communication
  • Management of Implementation of Process Modifications and External Commitments
  • Product Recall

 

 

Coda’s experience managing projects is as diverse as our project history including, but not limited to:

  • Capital Improvement/Expansion Projects – construction and qualification of new facilities, process scale up/technology transfer, validation of product processing lines, configuration, validation and implementation of global automation, PAI readiness management and preparation
  • Quality System Development and Implementation – Corporate Change Management, Problem Investigation, CAPA Management, Material Control and Lot Release, Document Control, Storage and Retention, and Training
  • Documentation Design and Generation – Operating procedures, protocols, Master Batch Records, Master Equipment Files, Label Control and Reconciliation forms, Material and Batch Reconciliation forms, Controlled Substance usage forms, requirement and specification tracking and management tools
  • Regulatory Compliance – Definition of responses to findings, Management of Implementation of Commitments, Implementation of Process Modifications

The correct mixture of experience, skills, and attributes means our leaders WILL:

LEADRather ThanMANAGE
InnovateAdminister
Focus on the FutureFocus on the current
Inspire TrustRely on Control
Ask “What?” and “Why?”Ask “How?” and When?”
BuildBalance
Do the right thingsDo things right

 

Training Classes

keyCoda Corp USA offers a fully developed training product line for all Service Centers. The standard courses offered to the market place have been designed to service industry sectors and business units. For instance, Quality Training for Biologics Companies or Design Control for Medical Device Engineers.

Upon receipt of a training request, Coda training managers assess the nature of the business and the unit requesting training, and select the most appropriate course work from our current library of training.

Regulatory Reference Handbooks are available with the purchase of any training program.