Overview of Select IPEC Guides through the Eyes of the New ANSI/NSF/IPEC 363 Standard Workshop Leader: Mr. Dale Carter (IPEC Americas)
Abstract:This workshop will review the requirements of the NSF/IPEC/ANSI 363 – 2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients and the connection to existing IPEC guidance documents (note: Guidelines available at www.ipecamericas.org). The content and application of supporting guides will be reviewed. An audit check list will be provided to attendees to use in taking notes during the presentations. ____________________________________________________________________________________
Colorcon Tablet Coating Workshop
Workshop Leaders: Gus LaBella, Formulation Technologies Manager - Charles Vesey, Regional Technical Manager -Laura Scattergood, Principle Area Technical Manager
Abstract: Focus of this half day workshop will be film coating of tablets in side vented coating pans. This session will give insight into tablet requirements, coating ingredients and their function, equipment and process parameter optimization as well as scale-up considerations. The session will conclude with a troubleshooting presentation discussing resolution to common coating defects.
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Integrity of the Excipient Supply Chain
Good Distribution Practices, Quality Agreements, Imports and the Role of the Distributor
Workshop Leader: Lead: Bretta Lichtenhan; Contributors/Presenters; Kathy Ulman, Priscilla Zawislak, Paul Fox
Abstract: Understanding the excipient supply chain is more important than it has ever been. As the complexity of our supply chains grows our need to understand it becomes essential to do business in today’s world. This workshop will focus on the expectations of the excipient manufacturer who supplies the excipient user and the role of the distributor as the key link in the supply chain. Specific presentations will be given on supply chain as it relates to quality agreements, FDA Imports, Good Distribution Practices and the role of the distributor. A question and answer session will follow with ample opportunity to discuss the supply chain issues that are meaningful to you and your Company.
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See more: http://www.excipientfest.com/index.php/schedule/workshops