Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations and Facility Requirements

Bethesda, MD
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

Biotechnology is the use of biological processes and components to provide useful products, services and tools for a variety of applications. Biological and drug products under the regulatory review and approval by the United States Food and Drug Administration are required to be manufactured in compliance with current Good Manufacturing Practices regulations (CGMPs). Sponsor organizations are expected to use appropriately designed facilities and to have in place phase-appropriate quality systems for clinical trial product manufacturing as well as for commercial product manufacturing.

This course is designed to expose participants to a variety of topics, including: biopharmaceutical product development, biomanufacturing strategies, the various types of products and their applications, the current requirements for CGMP manufacturing of biopharmaceutical products and how to plan for CGMP implementation in your facility, how to maintain a state of control during biomanufacturing, bulk plant design from a process/product perspective, architectural considerations and facility layout, and cleanroom requirements. The course format uses a combination of lecture and interactive group discussions with case studies.

Who Should Attend

Managers, group leaders, supervisors and manufacturing associates/technicians from units involved with GMP manufacturing of clinical and commercial supplies of biopharmaceuticals; staff from process development, quality control/quality assurance, engineering and regulatory affairs units.

Event Location
PDA Training and Research Institute
4350 East-West Highway, Bethesda, MD Get Directions

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More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Explain the biopharmaceutical product and process development steps
  • Describe and understand the key steps in typical biopharmaceutical manufacturing processes
  • Discuss CGMP requirements at an advanced level
  • Develop a plan to implement CGMPs in your operations
  • Learn how to anticipate GMP compliance problems
  • Develop effective approaches for establishing corrective and preventative action plans
  • Identify the issues involved with designing, building, equipping and validating a manufacturing facility for biological products under FDA CGMP compliance
  • Use relevant sections of the CGMP regulations in 21CFR and the ICH Q7 guidance to guide your facility decision making
Agenda is subject to change.

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PDA Training and Research Institute

4350 East-West Highway
Bethesda, MD ,

Antonio Moreira, Vice Provost, UMBC

Dr. Antonio R. Moreira is a well-known and highly regarded biotechnology expert in cell culture and fermentation bioprocessing. He holds a B.S. degree in chemical engineering from the University of Porto, Portugal and M.S. and Ph.D. degrees from the University of Pennsylvania. Dr. Moreira is President of Peritus Consultants, Inc., a consulting company specializing in the bio/pharma industries. He is Professor of Chemical, Biochemical and Environmental Engineering at the University of Maryland, Baltimore County (UMBC) where he holds the position of Vice Provost for Academic Affairs since 1997. Dr. Moreira has also been Chair of the Department of Chemical and Biochemical Engineering and Associate Dean of Engineering.

Prior to joining UMBC, Dr. Moreira spent ten years in the private sector, holding senior technical management positions with International Flavors and Fragrances, Inc. and Schering-Plough Corporation (now Merck & Co.). At Schering-Plough, he was responsible for the fermentation process development team that brought alpha-interferon to the market under FDA and many other international regulatory agencies approval. He was also responsible for the manufacture of biologics for the US market. He worked on additional biopharmaceutical products such as gamma interferon, GM-CSF, and IL-4.

Dr. Moreira consults for a number of biotechnology companies in process development, regulatory and CGMP compliance, and validation of facilities and processes. He has an active research program currently focusing on the production of biologics via mammalian cell culture, including issues related to regulatory science. He has authored or co-authored over 200 scientific publications and presentations. He is a frequent lecturer for the PDA-TRI and received the PDA James Agalloco award in 1997. Dr. Moreira was the Founding President of the Chesapeake Bay Area chapter of ISPE and was Chair of the Council of Biotechnology Centers of the BIO Industry Organization from 2001-2003. He is a graduate of Leadership Maryland, class of 1998.