Education Sessions

E-GU6
Overview and Application of ISPE Baseline Guide for Packaging, Labeling and Warehousing (PACLAW)

4 November 12.30–14.30 Track: Guides & Guidance Documents

ISPE CEUs: 0.2

This session at Annual Meeting will provide an overview opportunity to hear from the experts on the ISPE Baseline Guide for Packaging, Labeling and Warehousing that is now close to publication. Presenters are Guide contributors and will include the influence of Risk Assessment, Architecture, HVAC, Process Support, Utilities and Equipment Qualification on the operation of Packaging, Labeling and Warehousing Operations. In addition, the attendees will be provided with the benefits of the Guide through case studies to improve processes and increase productivity specifically for Risk Assessment, Commissioning and Qualification and Layout/Material Flows associated with Packaging, Labeling and Warehousing Operations. The session will also include a workshop on the application of the guide for a liquid/injectable, solid dose and warehouse operations. Please note that the Guide will not be distributed at this session

Take Back to Your Job

  • Understand the current drivers on packaging, labeling and warehousing operations
  • Assess their packaging, labeling and facility operations through the application of the guide to improve work processes and increase productivity
  • Explain the material and personnel flows required for safe and efficient operations
  • Analyze operations and assess risks of designing and commissioning and qualification of these facilities
  • Describe building design, HVAC considerations and adjacency impacts associated with a packaging, labeling and warehousing facilities

Who Should Attend

Quality Assurance Professionals, Engineers, Architects, Project Managers involved in facility design and/or rennovation and project execution.

Session Leader

  • Linda McBride, VP, Regulatory Affairs, Cogentus Pharmaceuticals

Session Speaker

 

Sponsors