Education Sessions

E-RC1
Design Standards for the Pharmaceutical Industry: A Round Table Discussion

4 November 12.30-14.30 Track: Regulatory / Compliance

ISPE CEUs: 0.2

Highly-participatory session

Get involved with shaping the industry standards of tomorrow! Representatives from ISPE, ASME-BioProcess Equipment Standard, 3A, Pharmaceutical-3A, and more, are looking you're your input to make the standards the best that they can be. Representatives will provide a brief description of the scope of their efforts, yesterday, today, and tomorrow, and how these efforts relate to each other. They will then ask the audience to join a moderated discussion on the general use of the standards, on where each standard/guideline best applies, and what the industry needs from the standards.

Take Back to Your Job

  • Understand intended audiences for each standard
  • Where the standards compliment each other and where they overlap
  • Understand how to influence changes to the standards

Who Should Attend

People who want to understand standards and influence the industry. Design engineers, project managers, validation engineers, department managers, quality and regulatory staff

Agenda

  • Review of the Industry Consensus Standards
  • Building and Fire Codes
  • ASTM and ANSI
  • ISPE Baseline Guides
  • ASME-BPE-R
  • P3A-B
  • Summary
  • Open Discussion

Session Leader

  • James Vogel, Principal, Process Facilities Services Inc

Session Speakers

 

Sponsors