Delivering Manufacturing Projects in a Risk-based World: The New Regulatory Paradigm and its Impact on Facility Design

The new FDA Guidance for Industry on Process Validation states that “activities undertaken to demonstrate utilities and pieces of equipment are suitable for their intended use and perform properly is referred to as qualification.” Today’s regulatory expectations for delivering facilities under a risk-based approach must focus on the intended use of the facility related to the product(s) being manufactured. This webinar discusses concepts of Good Engineering Practice (GEP) and Quality by Design (QbD) and also identify synergies with the new ASTM E2500 standard “Standard Guide for the Design, Specification, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment.” These new approaches for working under a risk-focused Quality Management System will introduce new concepts to project teams and change the way proven engineering/project management systems are implemented and reviewed by the FDA. At the conclusion of this session, participants will be able to:

  • Understand the impact of ICH Q8, Q9, and Q10 on manufacturing facility projects
  • Learn the requirements of GEP and how it should be implemented
  • Know how “state of control” applies to facility design in a risk-focused approach
  • Understand the impact of risk assessment and the role it plays in a risk-based design approach

Speaker Biography:
Jeff Odum has over 25 years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries. He is currently the Director of Operations and Biotech Sector Lead at IPS, leading the RTP Office in Morrisville, NC. A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over 60 articles on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to facility design, bioprocess, project management and GMP compliance. Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the Biotechnology Community of Practice and a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management and commissioning and qualification, and is a member of ISPE's technical training faculty. He has led training efforts in 15 countries, as well as in the US. He is also a Teaching Fellow in NC State University's BTEC graduate program in biomanufacturing and a guest Instructor for the North Carolina Community College System BioNetwork Program.


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