Education Sessions

Collocation of Development and Commercial Manufacturing
E-MG1

4 November 12.30-14.30 Track: Manufacturing

ISPE CEUs: 0.2

Collocation of development and commercial manufacturing should be carefully considered from several points – contamination, mix-ups, and differences between training and procedures – all of which the regulators scrutinize.

This session presents a practical approach to the facility, utilities, equipment, raw material, processing, and personnel challenges of producing development and commercial products within the same facility. Raw material selection and segregation, equipment qualification and cleaning, environmental classification and monitoring, operations/material segregation and flow, as well as personnel training and practices are explored in depth. Case studies and recent regulatory citations are used to compare and contrast various approaches to successfully optimize a shared manufacturing operation.

Take Back to Your Job

  • Distinguish the necessary factors when considering the collocation of development and commercial manufacturing operations
  • Use practical approaches to facilities planning in dual environments
  • Successfully operate shared production facilities

Who Should Attend

Those involved in the design and/or operation of facilities which are shared by development and commercial manufacturing, as well as development, engineering, manufacturing, quality, regulatory affairs and validation professionals in the biotechnology, drug and device industries.

Session Leader

Session Speakers

  • Bradley Kosiba, Senior Director, Wyeth
  • Blair Tyson, Sr Mgr Aseptic Ops, EISAI
  • Eric Unrau, Project Manager, CRB Consulting Engineers, Inc.
  • Hobert Williams, Mgr, Engineering & Capital Projects, Wyeth Research

 

Sponsors