Applying the Biomanufacturing Facilities Baseline Guide (Volume 6, 3rd Edition): Case Study Examples that Define the Basis of Design
his session will present two case study vignettes where life sciences companies used the Baseline Guide concepts to form the basis of design for a new manufacturing asset. The case studies focus on key guiding principles that identify the synergies between process closure, operation efficiency, contamination risk mitigation, and facility optimization. Specific references to the Baseline Guide will be provided as part of the interaction with the Audience.
3.0 PDH (Professional Development Hour) credits will be offered upon completion of this event (Only issued to attendees who elect PDH credit option during registration process; no additional charge for PDH certificate).
IMPORTANT: Please use your company e-mail address during registration.
OWNER COMPANY : Must use End-User/Owner Company e-mail address for complimentary registration.
Agenda:
5:00 - 6:00 PM Networking and Dinner
6:00 - 7:30 PM Presentation
7:30 - 8:00 PM Q&A Session
Speakers:
Jeff Odum, CPIP, is a globally recognized SME in Biomanufacturing Facilities with over thirty years of experience in the development, design, construction, and delivery of facilities in the biotechnology Industry. A recognized expert in biopharmaceutical manufacturing assets, Mr. Odum has authored over 60 published articles and four Industry reference books on subjects related to biopharmaceutical manufacturing facility assets. He is a recognized speaker at international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project development, 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), past Chair of the ISPE Global Biotechnology Community of Practice, and a contributing author to numerous industry baseline and reference guides focused on ATMP and biotechnology manufacturing, process development, project delivery. He is a member of the ISPE Technical Training Faculty and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing. He has led training efforts in fifteen countries in over 100 sessions, including training for global regulators from the US FDA, Health Canada, Thailand FDA, FDA-COFEPRIS, and the Chinese SFDA.
Marc is Senior Fellow, Biochemistry at CRB. His roles include strategic planning, conceptual design, process engineering, risk assessments and regulatory compliance. He has been in the industrial biopharmaceutical biotechnology sector for over 40 years. Marc has been prolific writer of standards, guides and white papers for the ASME BPE, ISPE, Biophorum and numerous other publications and societies. He served as the Chair of the ASME BPE Executive Committee. He is an author of the recently published 3rd ed of the ISPE BG Volume 6 Biopharmaceutical Manufacturing Facilities and Biophorum Process Closure Playbook. His proudest accomplishment is the publication of the harmonized ISPE/Biophorum Lexicon.
Registration Information:
| COST | |
|---|---|
| ISPE Members | $70 |
| Non-Member | $90 |
| End-User/Owner | $0 |
| ISPE Member Emerging Leader | $45 |
| ISPE Member Student | $0 |
| Non-Member Student | $25 |