New GMP Professional Development Course Offered by BTEC

Aug. 22, 2011 - PRLog -- The Biomanufacturing Training and Education Center (BTEC) at NC State University will hold a new three-day professional development course—Process Architecture:  Integrating the Process to DeliverSuccessful Facility Solutions—October 12-14, 2011, at its facility on the university’s Centennial Campus.

Jeff Odum, director of operations at Integrated Project Services (IPS), North Carolina, is the course instructor. Odum has more than 20 years of experience in regulatory compliance, facilities and process design, and project management for global biopharmaceutical companies. Victor Warren, president of Warren Architects, Inc., and a licensed architect in California and Washington with nearly 30 years of comprehensive facility development practice, will assist Odum. Jason S. Collins, RA, NCARB, will also help facilitate the course.  Collins, a senior process architect at IPS, has conceptualized and led design and construction services for various pharmaceutical facilities.

According to Odum, Process Architecture: Integrating the Process to Deliver Successful Facility Solutions provides the critical information and concepts required to develop a facility design that meets current global regulatory guidelines for Good Manufacturing Practice (GMP) focused on risk-based implementation. The course includes review of case studies and hands-on design activities in addition to lecture. The design process will be defined to provide “robust design” that is based on Quality by Design (QdD) principles. The course is designed around current industry and ICH guidance with a focus on meeting the new Process Validation guidance, which includes reference to new qualification principles for biomanufacturing facilities.

Registration is now open, and attendees will earn 2.1 continuing education units (CEU). The $1,950 course fee includes three days of instruction, an ISPE Pharmaceutical Baseline® Guide, lunches and beverages. For more information, visit go.ncsu.edu/facility_solutions or the BTEC website at www.btec.ncsu.edu.

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Centennial Campus is an award-winning a research park and campus owned and operated by NC State University.