mosierPrintableHeader (3K)

Success Stories

FDA Recall and Replacement

Need

A leading global biomedical company discovered a manufacturing problem during their quality assurance testing. After filing their notice with the FDA (Federal Drug Administration), they were then faced with the task of creating and managing the replacement process to meet both company and FDA standards. A senior level project manager from MosierMcCann was the ideal solution to ensure the replacement process was a success.

Actions

  • Created internal processes to contact the purchasers of the product to facilitate the installation of the correction kits.
  • Integrated FDA tracking and reporting requirements with internal tracking and reporting processes.
  • Communicated to management team with weekly status reporting.
  • Coordinated with various vendors, distributors and international contacts to facilitate replacements.
  • Provide detailed replacement instructions, Q&A, and personalized step-by-step processes.
  • Managed a variety of resources and stakeholders including business managers, engineers, vendors, and administrators.

Results

  • Completed project early due to thorough processes and effective project management.
  • Realized significant cost savings due to higher than projected replacement and adoption rates.
  • Achieved high customer satisfaction feedback.
  • Complied with FDA process and tracking requirements.

Need

A leading global biomedical company discovered a manufacturing problem during their quality assurance testing. After filing their notice with the FDA, they were then faced with the task of creating and managing the replacement process to meet both company and FDA standards. A senior level project manager from MosierMcCann was the ideal solution to ensure the replacement process was a success.

Actions

  • Created internal processes to contact the purchasers of the product to facilitate the installation of the correction kits.
  • Integrated FDA tracking and reporting requirements with internal tracking and reporting processes.
  • Communicated to management team with weekly status reporting.
  • Coordinated with various vendors, distributors and international contacts to facilitate replacements.
  • Provide detailed replacement instructions, Q&A, and personalized step-by-step processes.
  • Managed a variety of resources and stakeholders including business managers, engineers, vendors, and administrators.

Results

  • Completed project early due to thorough processes and effective project management.
  • Realized significant cost savings due to higher than projected replacement and adoption rates.
  • Achieved high customer satisfaction feedback.
  • Complied with FDA process and tracking requirements.