Standards education leads '02 World Batch Forum

Woodcliff, N.J. - Standards issues were among topics of discussion for 80 World Batch Forum (WBF) end-users and 120 supplier/integrator/consultants, from around the world.


Woodcliff, N.J. - Standards issues were among topics of discussion for 80 World Batch Forum (WBF) end-users and 120 supplier/integrator/consultants, from around the world. The group met here April 7-10 to share experiences, learn about industry impacting topics, and identify future batch user needs.

Not wanting to waste a single minute, WBF sessions titled 'Applying the S88.01 Standard,' 'S95 Tutorial,' and 'Process Modularization Clinic' were held Sunday afternoon followed by the second annual 'Hall of Fame' dinner honoring this year's inductees Terry Tolliver (Solutia, St. Louis, Mo.), Marion 'Bud' Keyes (Emerson Process, St. Louis, Mo.), and Harrold Wade (Wade Associates, Houston, Tex.).

Monday kicked off with an insightful keynote address by Michael Templeton, director of manufacturing at Millennium Specialty Chemicals (Jacksonville, Fla.). Mr. Templeton candidly explained how Millennium is using industry standards, a comprehensive 'pay as you go' technology plan, and a work force organized around the plan to become a best-in-class specialty chemical producer. Throughout the technology plans development, Mr. Templeton said he was insistent the plan should be more than a vision or set of goals. According to Mr. Templeton, Millennium's plan was developed based on gap analysis discovered following benchmarking activities conducted with peer specialty chemical producers.

Tuesday's keynote speaker was Martin Browning, president of EduQuest (Hyattstown, Md.). Prior to forming EduQuest, Mr. Browning spent 22 years working for the U.S. Food and Drug Administration (FDA, Rockville, Md.) and is one of the chief architect's of the 'Electronic Records and Electronic Signatures' regulation, also known as 21 CFR Part 11. One of Mr. Browning's key points was that most people are nervous when talking to FDA investigators and tend to be inconsistent in their responses to investigator questions. Mr. Browning said, 'The more nervous you are, the more interested FDA investigators become. When an FDA investigator ask what a system does, users should be able to recite a simple one or two sentence description and end it.'

Another insight Mr. Browning shared was FDA investigators tend to focus on one area, peeling away layers as they ask more questions. Mr. Browning added they also work with sweeping generalities. While at a user's site, an FDA investigator may look at how audit trail, for example, is implemented on three out of 500 systems and pass judgement on the 500 based on the findings of the three.

For more on this topic, see Control Engineering's April '02 article on 21 CFR Part 11, 'I'm from the Government, and I'm Here to Help You.'

Other WBF activities of interest to the entire batch processing industry included the announcement of two sets of XML (eXtensible Markup Language) schemas, BatchML and B2MML, along with the announcement of a series of web-based seminars on batch-related topics.

The XML schemas, developed by a WBF working group, are designed to help streamline and simplify batch recipe and batch control application development and business-to-manufacturing data exchanges. Both schemas are available as free downloads to vendors and end-users via .

The batch-related web-based seminars are scheduled to begin in June, and extend through the end of 2002. For more information about seminar topics, visit the WBF calendar page at .

Control Engineering Daily News Desk
Dave Harrold, senior editor

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