Education Sessions
Design Standards for the Pharmaceutical Industry (405)
| 29 October 08.15-11.15 | Track: Engineering Design |
ISPE CEUs: 0.2
(PDF Current as of 9 September 2008)
Get involved with shaping the industry standards of tomorrow! Representatives from ISPE, ASMEBioProcess Equipment Standard, Pharmaceutical- 3A, and more, are looking for your input to make the standards the best that they can be. Each representative will provide a brief description of the scope of their efforts, currently and on the horizon, and how these efforts relate to each other. There will be a special focus on facility standards and the new IBC L-Classification for Laboratories in California, and soon to come to other jurisdictions. COP questions regarding standards will also be reviewed and the audience will participate 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 - www.ISPE.org/publications
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
Session Leader
- 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