Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations and Facility Requirements
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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.
Time: 8:30 a.m. - 4:00 p.m.
Agenda
Discover What's Happening Each Day
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
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
PDA Training and Research Institute
4350 East-West HighwayBethesda, 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.
Registration
Pricing Options
More information coming soon.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #459 | ACPE #0116-0000-14-009-L04-P | 1.2 CEUs
Type of Activity: Knowledge
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 12 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 12 PDHs.
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