Op Ex & Lean Six Sigma / cGMPs / Facilty Design & Management

Macher and Nickerson on Benchmarking Pharma and FDA

Georgetown Professor Jeffrey Macher and Washington University Professor Jackson Nickerson discuss their extensive benchmarking project, which analyzed FDA regulation, in particular cGMP inspections, as well as industry manufacturing performance.

By Agnes Shanley, Editor in Chief

In the following audio interviews, coauthors of the extensive Pharmaceutical Industry Benchmarking project, Professor Jeffrey Macher of Georgetown and Professor Jackson Nickerson of Washington University discuss the project and where it may lead.

  • Part 1:
  • Looks at the project, challenges, and some conclusions regarding employee empowerment, PAT and operational excellence. Click the Download Now button below to download Part 1.

  • Part 2:
  • Examines extent and use of IT and emphasizes the lack of cause and effect analysis so far. Click here to download Part 2.

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