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I joined ISPE with the hope of giving something back to an industry that has served me well over the last 15 years. After attending one conference, I knew I wanted to become an active Member in the organisation. I wanted to have a role in ISPE activities and events that benefited other industry Members. I found the transition from attendee to active Member relatively easy. Despite the fact that ISPE is a society made up of volunteers, passion and professionalism in which business was conducted was eye opening. In my 10 years as a Member, I have made many friends who have afforded me the benefit of their experience within OUR industry and have changed both my professional and social view point. ISPE is a wonderful organisation and I hope to be part of it for years to come.
Nigel Frost, Managing Director
Thermal Transfer, Ltd., United Kingdom
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True Stories: What it means to be an ISPE Member - (WMV, 16 MB)
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Recorded Webinars |
Formulation, Clinical Phases, and Manufacture
Knowledge Element: Product Development
Session Type: Recorded Webinar
Speaker: Charles F. Carney, Seraphim Life Sciences Consultants LLC
Duration: 60 minutes
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Research and development of drug substance and drug product form the basis for adequate performance of medical research. The R&D efforts culminate in the consistent manufacture and control of a product that can be administered to man that will deliver the drug substance to the human body in a known and predicted manner in order to achieve the desired pharmacologic effect of that drug substance. These efforts require deep understanding of the disease state being treated as well as the full characterization of the capabilities and limitations of the finished product to deliver the drug to attack the disease.
This seminar will be a high level overview that will describe the extensive knowledge that must be gained of the physical chemical nature of the active drug substance and of the inactive ingredients, of analytical procedures that must be developed for quantification, and of the choices and limitations of the processing equipment and unit operations required in order to manufacture reproducibly the appropriate dosage form. The presentation will include information about typical discovery and development interactions with other functions in the organization such as medical research, regulatory affairs, marketing, and commercial production to name a few.
The requirements for including consideration of the interactions of the manufacturing process steps with the material characteristics which can influence the consistent production of product and the consistency of delivery of active drug from that product will be covered as will the quantitative characterization of substance and product. These analytical tasks include the development and validation of analytical methodologies which can be used both for answering research queries about the drug and dosage form but also can be used for quality control of each lot of drug substance and drug product. These quantitative data provide the evidence to confirm the adequacy of the finished product to perform as intended. Packaging, labeling, and warehousing issues, including transportation and distribution topics will also be reviewed. The phases of clinical trials and the information gained from each phase will be described and related to the development and delivery of the appropriate strength dosage form, properly packaged and labeled.
Learning Objectives:
- How medicinal chemistry synthesis of new drug substances and use of these substances in animal pharmacology studies support product development and medical research
- How drug discovery groups interact with drug development groups to design, produce, and control the best administration dosage form for the drug
- What information is gained from each of the four phases of human clinical trials
- How decision pathways must be developed within organizations to ensure that the tasks and outputs from each of the contributing groups, discovery, development, medical research, marketing, regulatory affairs, and commercial manufacturing is coordinated effectively to bring a drug to market
- The criticality for understanding and utilizing the physical and chemical characteristics of active drug substance and of any inactive ingredients in the finished dosage form to ensure the consistency from lot to lot of drug product in delivery of drug in the body
- The interactions between the physical chemistry of the ingredients with the manufacturing process steps of the production equipment in producing consistent lots of the dosage form
- The necessity for the parallel development and validation of analytical methodologies specific to the particular ingredients and the finished dosage form in order to confirm the quality attributes of the finished dosage form
- How finished goods logistics, including warehousing, transporting, and distributing, support the ongoing supply of product maintained according to its requirements for temperature and humidity range in clinical trials and ultimately in the commercial product supply stream
Who Should Attend:
- Pharmaceutical product development professionals who will develop formulation and manufacturing processes for new medicinal products
- Production operations professionals who want a better understanding of how a formulation and manufacturing process is developed
- Other pharmaceutical professionals who want an overview of the breadth of issues involved in formulation and process design for new medicinal products
Speaker Biography
Charles Carney has nearly 40 years of experience in pharmaceutical drug product development, manufacturing, and analytical control. For the last 15 years of his corporate service he was the associate director of investigational supplies in the Connecticut R&D Center of Boehringer Ingelheim. Since 2003 he has been a consultant for Seraphim Life Sciences Consulting, LLC. His responsibilities have included performing and managing pharmaceutical, analytical, and GMP compliance aspects of drug product development, including the outsourcing, validation, and technology transfer aspects and the quality control, and facility design for commercial drug products. He is a co-editor of the second edition of “Drug Products for Clinical Trials.”
What is a Recorded Webinar?
Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.
What are CPIPSM Recorded Webinars?
CPIPSM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) examination..
The Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.
 See all available Recorded Webinars
Technical Requirements and FAQs
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