Pharma / Biotech
This course is designed to provide attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. The topics discussed during the course will be presented to explain the physical, physicochemical, biochemical, and engineering principles of the science and engineering behind modern freeze-drying. The practicality of the course allows the attendees to get a firm understanding of the theoretical applications of freeze-drying and how these can be easily used and applied to their day to day lyophilization projects.
Topics covered will include:
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
This two-day lyophilization training course is designed for those in the pharmaceutical, biomedical, medical device/diagnostic, and biotechnology industries who develop and/or produce lyophilized (freeze-dried) products. This includes, but is not limited to, professionals in Quality Control, Quality Assurance, Validation, Pharmacists, Managers, Microbiologists, R&D Groups, Biochemists, Pilot Plant Operators, Chemical Engineers, Production Supervisors, Chemists, Equipment Maintenance, and Mechanical Engineers. The course will also benefit those in other departments who find lyophilization among their responsibilities.
Module 1: Introduction:
Module 2: Lyophilization Equipment System Components
Module 3: Basic Principles Supporting Freezing Drying
Module 4: Regulatory Rationale
Module 5: Solution Development
Module 6: Freezing Development
Module 7: Package Selection
Module 8: Primary Drying Sublimation
Module 9: Secondary Drying – Desorption
Module 10: Process Overview
Module 11: Installation Qualification
Module 12: Operational Qualification
Module 13: Preventative Maintenance
Module 14: Performance Qualification
Module 15: Process Validation
Module 16: Equipment Trouble Shooting
Module 17: Case Studies of Failed Product
Module 18: Case Studies of Failed Process
Upon completion of this course, attendees will have a clear understanding of both the scientific and practical principles behind the formulation and development of lyophilized products. Additionally, participants will gain a firm understanding of lyophilization equipment including system operation, system components, system maintenance, system troubleshooting, IQ/OQ, and system validation. Attendees will also gain practical experience in applying what they have learned by working through several case studies in failed products and cycles. This course is presented in a very practical manner, so attendees will be able to quickly apply what they have learned to their lyophilization projects.
"The lyophilization training course has great technical and very informative material to understand the science behind lyophilization process and the potential problems that may occur during production." Ella H., QA Manager, Gilead Sciences
"The Course Director was very knowledgeable and his real life experiences made the course that much better. He knows what he is talking about!" Kevin D., Director of Manufacturing, J&J
"Since I don't operate the machines or design product cycles I came to this course not knowing what to expect. The result of the course and discussions with instructors and attendees has given me the inspiration to become involved with the freeze-drying processes at my company in the future. The discussions not only gave technical information but brought the processes to my level of interest." Dan M., Bioreagents Technologist, Instrumentation Laboratory
"This was a very good review/introduction to lyophilization. I didn't have much background in any of this when I arrived, but now I feel like I can begin to ask the right questions and to focus on our particular application of freeze drying." John C., Bioreagent Technologist, Instrumentation Laboratory
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*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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