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CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
16 October 2014
Who Should Attend
This broadly based course is intended for operators, troubleshooters and all scientists and technologists concerned with the development and processing of softgels capsules products and with related regulatory affairs.
The material will be presented in such a way as to be of value to a varying level of expertise. This course will especially benefit those in:
• Formulating
• Manufacturing/Production
• Engineering Support
• R&D
• Quality Assurance
• Marketing
• Validation
• Purchasing
• Regulatory Affairs Description
The main aim of this course is to review the science relating to softgel encapsulated pharmaceutical and nutritional products. The course begins with a consideration of the basic aspects of softgel manufacturing process, progresses through raw material/ingredients and their properties to the formulation of these ingredients for softgel both the fill and the shell materials to meet the needs of the manufacturing process. Experimental designs and QbD is considered in determining robustness of the prodcuct/process. The program concludes with key aspects of the evaluation of finished products and the investigation and troubleshooting to solving problems.
Formal sessions of the course are supplemented with informal discussion periods between lecturers and course participants and problem-solving sessions are held on both an open and private basis.
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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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Dr. Cecil W. Propst; Director R&D, SPI Pharma, Inc., Grand Haven, MI
Dr. Cecil W. Propst is Director of R&D for SPI Pharma (Grand Haven site), a processor of a variety of specialty ingredients for the food, drug, cosmetic and related industries. He was Director of Quality Assurance and Technical Development at Fleming and Company and President of Manufacturing Chemists. His duties included system design, product and process development, and regulatory affairs. Previously, he served as cGMP Facilities Director for the University of Maryland at Baltimore in connection with the University's contract with the FDA.
Dr. Propst also served as Director of Technical Development for Stellar Manufacturing, Director of Quality Compliance for SmithKline Beecham, Director of Quality Assurance for Norcliff Thayer (a Revlon Company), Group Leader/Product Development and Manager/ Quality Control for Lewis Howe Company.
Ronnie Bayless; Consultant/Owner, Bayless Technologies, Inc.
Ronnie Bayless, a consultant/owner in the area of Softgel development/processing for Bayless Technologies, Inc. in Plant City, Florida, has over 25 years of practical, hands-on experience in many areas of polymer science from Research and Development to solving manufacturing process problems. Mr. Bayless specializes in the areas of paintball and pharmaceutical softgel technologies, medical polymers, and polymer characterization. He is experienced in employing scientific methods to develop new technologies, products, and processes including complete implementation into manufacturing and the application of Statistical Process Control and Design of Experiments methods to improve process quality. Mr. Bayless' has also:- Worked in research project management, scheduling, budgeting, and resource allocation
- Developed gelatin solution manufacturing processes for use in pharmaceutical softgel capsules
- Validated processes for use in a FDA approved facility
- Developed and implemented paintball product compositions from concept to stabile manufacturing
- Established and administered Quality Control systems for raw materials used in the manufacture of paintballs and cosmetic capsules
- Established raw material specifications, test methods and documentation
- Established finished product standards and test methods. United States
- Been granted patent for paintball fill composition
- Participated in ASTM meetings and contributed proposals to establish paintball standards
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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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