Webcast

Design Standards for the Pharmaceutical Industry

Duration: 2.5 hour
ISPE CEUs: 0.2

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Representatives from ISPE, ASMEBioProcess Equipment Standard, Pharmaceutical- 3A, and more provide a brief description of the scope of their efforts, currently and on the horizon, and how these efforts relate to each other. There is special focus on facility standards and the new IBC L-Classification for Laboratories in California, and soon to come to other jurisdictions. Questions regarding standards are reviewed in a moderated discussion on the general use of the standards, where each standard or guideline best applies, and what the industry needs from the standards in the future.

How You Will Benefit

At the end of this session, participants will be able to:

• Identify current activities with ISPE, IBC, ASME and P3A on codes, standards and guidelines
• Describe new and developing standards and current trends that are emerging
• Apply the standards to their own jobs and company projects

Technical Documents

• ISPE Baseline® Guide Series

Who Should Attend

People who want to understand standards and influence the industry such as design engineers, project managers, validation engineers, department managers, quality and regulatory staff

ISPE Communities of Practice (COPs)

• All COPs

Seassion Leaders

• James Vogel, Principal, Process Facilities Services Inc, USA

Session Speakers

• Reinhard Hanselka, Principal Chemical Engineer, IES, USA
• William Huitt, Owner/President, W. M. Huitt Co., USA

Continuing Education Units or CEUs are a way to document time spent in educational programs. ISPE CEUs are calculated as follows: 1 CEU = 10 hours of education time. Thus 0.1 CEU is equal to one hour of education. Download a form to apply for the CEUs for this program.