Examine the changing relationships between regulatory guidance defined in the GMPs and facility attributes that focus on “robust” facility design for biomanufacturing.
Trainees participate in a design activity during a course at BTEC.
Who should attend:
• Anyone interested in acquiring the critical knowledge
of biomanufacturing facility design necessary to meet current GMP guidelines
• Professional architects and engineers involved in biomanufacturing facility design
• Engineers and Quality professionals involved in facility qualification and validation
• Facility engineers • Regulatory Affairs professionals • Compliance auditors and managers • Strategic consultants • Process equipment suppliers • Biomanufacturing support personnel • Project managers responsible for conceptual design projects
• Graduate students in biomanufacturing and/or regulatory compliance
The key to Your Facility’s Success Phone: (919) 513-2000 Fax: (919) 513-8235 Email: firstname.lastname@example.org Web: www.btec.ncsu.edu GPS: 35.773014, -78.673868 Photo by Roger Winstead, NC State Univ. Communication Services
850 Oval Drive Suite 195 Raleigh, NC 27606
North Carolina State University Campus Box 7928 Raleigh, NC 27695-7928
Process Architecture Integrating the Process to Deliver Successful Facility Solutions October 12-14, 2011
Attend and you will receive:
300 copies of this public document were printed at a cost of 71¢ per copy. This document was printed on paper with 10% recycled content.
se ur co da y
• Certificate of
NC State University is dedicated to equality of opportunity. The University does not condone discrimination against students, employees, or applicants in any form. NC State commits itself to positive action to secure equal opportunity regardless of race, color, creed, national origin, religion, sex, age, or disability. In addition, NC State welcomes all persons without regard to sexual orientation.
lunch and afternoon beverage break
• ISPE Pharmaceutical
• 2.1 CEUs • Morning coffee,
Process Architecture - Integrating the Process to Deliver Successful Facility Solutions
A 3-day professional development course October 12-14, 2011
Biomanufacturing Training and Education Center (BTEC) NC State University Centennial Campus 850 Oval Drive Raleigh, NC 27606 Through lecture, case study review, and design problem activities, this course 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 design process will be defined to provide “robust design” that is based on Quality by Design (QbD) 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.
• Students will be provided the tools and references to develop design solutions for a given aseptic manufacturing concept.
• Students will work in teams to provide a design solution to a project risk assessment based on process and facility attributes.
• Students will then use the BTEC facility as a
model to develop and present a conceptual design case study.
Jeff Odum leads a discussion during a course on facilities and utilities at BTEC.
Attend and you will learn:
• The impact of the new regulatory paradigm on facility design
• How to implement risk-based facility design concepts • Current trends in aseptic manufacturing design • The impact of Quality by Design (QbD) on facility design attributes
• How to assess the impact of new platform technologies on facility design philosophy
• How to recognize the impact of operational philosophy on facility design
• How to design to meet the requirements of the new Process Validation guidance
Register Now Instructors Jeff Odum, assisted by Jason Collins and Victor Warren Cost: $1950 20% discount to BMF member companies or any company enrolling more than 5 employees; 50% discount for academic affiliated faculty/staff.
To register for this course, access our online registration system at http://go.ncsu.edu/processarch or scan the QR code at the right with your mobile device.
Jeff Odum, Director of Operations at Integrated Project Services (IPS), North Carolina, has been involved in the biopharmaceutical industry for more than 20 years. He is a recognized author, speaker and industry consultant who provides industry insight in the areas of regulatory compliance, facilities and process design, and project management for many global biopharmaceutical companies. Mr. Odum’s experience in the biopharmaceutical industry has included many of the industry’s major manufacturing projects, as well as consulting roles for a number of the global biotechnology and pharmaceutical industry leaders. As a recognized subject matter expert, he provides facility and quality system audit services for companies preparing for FDA and EMEA inspections. Mr. Odum also provides consulting services for companies to assist them in their regulatory filings related to facility design and operation. Jason S. Collins, RA, NCARB, Lead Process Architect at IPS, is a premier process architect developing concepts of pharmaceutical facilities for various clients around the world. He uses 3-D modeling and unique visualization techniques to take clients through the conceptual layout phase and for the development of unit operations. Mr. Collins is experienced in detail architectural design and construction-related services. He has conceptualized and led the final design and construction services for state-of-the-art, sterile facilities both small and large. Victor Warren, President of Warren Architects, Inc., is a licensed architect in California and Washington. He has practiced architecture for nearly 30 years, dedicating the last two decades to strategic and capital facilities planning and process architecture for biotechnology and pharmaceutical facilities. He brings firsthand knowledge of facility development from start to finish: strategic planning, capital project planning, feasibility analysis, facility programming, conceptual design, project management, and project control systems through to the final construction punch list.