April, 2003

When the University of MA-Lowell, Chemical Engineering Department decided to develop and teach a course on FDA BioPharma Validation requirements they turned to their Board of Advisors. Bob Konopacz, Senior Director of Wyeth, Joe Musiak, Associate Director of Process Engineering at Biogen IDEC, and Rick Pierro, President of Superior Controls volunteered to form a Validation Subcommittee and, with Professor Carl Lawton, the team developed an outline for the Validation Course.

In addition, each of the three board members developed and presented a lecture for fifty students in Professor Lawton's "Biotech Regulation" course. Not one student fell asleep. Rick Pierro and Patty Ascanio of Superior Controls presented "Validation Requirements and Procedures for Automation and Information Systems". Joe Musiak focused on "Validation Requirements for Skids and Purchased Equipment" and presented Biogen's North Carolina expansion as an example. Bob Konopacz wrapped it up with a fascinating talk on "Validating the Proces". Interesting, real life stories, shared by all three speakers, helped keep students awake.

Professor Carl Lawton pointed out, "The students' feedback was incredible- they were amazed and impressed that FDA validation requirements can be so wide ranging an complex." All three speakers agreed to lecture again at next yea's course.