Active Pharmaceutical Ingredient (API) and Drug Product Specifications™
Course - King of Prussia, PA, United States
This comprehensive three-day Active Pharmaceutical Ingredient (API) training course is valuable to R&D personnel involved with researching synthetic routes, scaling up and manufacturing APIs. Those responsible for achieving technology transfer, as well as, generating CMC data for all regulatory filings from IND to NDA will also benefit from this course. Chemists and chemical engineers in process R&D who perform, supervise, or manage process scale up for the manufacture of pharmaceuticals will find this course valuable.
The course is also important to those in other departments who participate in work surrounding the manufacture and release of APIs. This includes manufacturing chemists preparing API under cGMP protocols for clinical and non-clinical use; formulations personnel converting cGMP API to finished dosage forms; as well as analytical chemists involved with stability testing, assays, methods development and drug release.
Personnel in Regulatory Affairs, Quality Assurance, and the Quality Control laboratories who are involved in cGMP/cGLP activities will also benefit by acquiring an in-depth knowledge of FDA regulations and ICH guidelines
This continually updated course covers the entire gamut of operations in the development of a New Chemical Entity (NCE) - from discovery to the filing of a New Drug Application. Emphasis will be placed on discussing stability issues, impurity profiles, polymorphism, bioequivalence, bioavailability and chemical route selection. Upon completion of this course, attendees will have a clear understanding of the many factors implicit in chemical route selection. Participants will also understand the specifications needed to meet current FDA regulatory requirements and ICH guidelines. Selected case studies will be presented to exemplify the concepts covered throughout the course.
(Courtesy of Philadelphia's architectural heritage, en.wikipedia.org)
Active Pharmaceutical Ingredient (API) and Drug Product Specifications™
Mon, Dec 03, 2012 - Wed, Dec 05, 2012
Doubletree Hotel by Hilton, Philadelphia/Valley Forge
301 West Dekalb Pike, King of Prussia, PA 19406, United States
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