Thursday, August 24 - Friday, August 25, 2017
DAY 1: 2:00 - 5:15 pm | DAY 2: 8:30 am - 3:15 pm
Instructor: Jeffery Odum, MSc, CPIP, Global Technology Partner, NNE; Managing Partner, Strategic Manufacturing Concept Group
Introduction
Biomanufacturing organizations today are looking for best practice approaches to create flexible manufacturing assets to support overall business needs. With expanding product pipelines and the introduction of new technology platforms, creating an asset that will not only have a long lifecycle expectancy but one that will also be flexible to meet development and commercial launch needs is a paramount business goal.
This two-day course will introduce attendees to the key facility design considerations that are needed to ensure the creation of a design concept and approach that will yield highly flexible, optimized, and highly utilized manufacturing assets. Key concepts will include development and understanding of a manufacturing enterprise model, the product-process-facility paradigm, “design-to-operate” methodology, appropriateness of GMP design compliance, and the identification and mitigation of risks around a sound QRM approach.
The course will implement traditional lecture components, class exercises, and the use of case studies as learning tools.
Course Outline
DAY 1
- Introduction to the Enterprise Model
- Design Considerations
- The QbD Approach to Facility Design
- Regulatory Considerations and Guidance
- Process Definition and Unit Operations
DAY 2
- Equipment Considerations and Technology Impact
- Facility Considerations and Design Attributes
- Risk Assessment
- Process Validation
Who should attend?
- Process Development Engineers & Managers
- Manufacturing/Operations Engineers
- Project Managers
- Quality Assurance Engineers
- Consultants
- Compliance Managers
About the Instructor
Jeff Odum is the Managing Partner, Strategic Manufacturing Concept Group, and a Global Technology Partner at NNE in the US Office located in Research Triangle Park, North Carolina. He has over twenty-five years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, pharmaceutical, and chemical industries.
A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over seventy articles and three industry reference books 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 next generation facility design, bioprocess manufacturing, 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 ISPE Biotechnology Community of Practice Steering Committee, and is a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management and commissioning and qualification. He is also a member of both the PDA and ISPE technical training faculties. He is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program. He has led training efforts in fifteen countries, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.
Training Seminar Information
Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.
Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.
