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CfPA - The Center for Professional Advancement, New Brunswick, NJ
April 23-24, 2012
Who Should Attend
This course is designed for personnel in the pharmaceutical, diagnostic, biomedical engineering and biotechnology industries responsible for the specification, development and production of lyophilized products, including:
• R & D Personnel
• Chemists
• Pilot Plant Operations
• Chemical Engineers
• Production Supervisors
• Microbiologists
• Managers
• Pharmacists
• QA/QC
Those new to the industry and those with previous experience will find the course beneficial. Description
This course presents the principles and techniques of lyophilization based on theoretical concepts and practical examples. Scientific aspects of aqueous systems, phase transitions, collapse phenomena are explained. Emphasis on pharmaceutical aspects including formulation, stability, cycle development, process scale-up, and analytical instrumentation is provided. Regulatory requirements including cGMPs, validation and qualification will be discussed. Engineering elements of heat and mass transfer, process control, and lyophilizer qualification are reviewed as well. The principles presented will be related to practical industrial examples throughout the course.
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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John F. Engelhart; Sr. Director, Quality Assurance, Aveva DDS
John F. Engelhart is currently Sr. Director, Quality Assurance, at Aveva DDS. He has over 20 years experience in parenteral (liquid and lyophilized proucts) and non–parenteral dosage form development, manufacturing, scale-up, technology transfer and process validation. Previously Mr. Engelhart held positions of Sr. Director, QA, Director, Formulation Development and Manager of Process Development at Organon (now Merck). Prior to that he worked at Schering Plough and Beecham Laboratories (now GSK) in process validation and sterile lyophilized product manufacturing. He received a BS in Chemical Engineering from Lehigh University and an MS in Pharmaceutical Sciences from Rutgers University.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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sberg@cfpa.com
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