This comprehensive three-day 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.



Learning Objectives

This course provides a comprehensive understanding of operations involved in the manufacture and testing of APIs for non-clinical and clinical use. Diverse facets of parameters involved in determining specifications for Active Pharmaceutical Ingredient (API), raw materials, intermediates, drug products, excipients and placebos will be discussed.  Curriculum will outline and detail the issues and guidelines incorporated in FDA guidances and ICH regulatory guidelines. Upon completion of this course, attendees will have a clear understanding of the many factors implicit in chemical route selection and specifications to meet regulatory agency expectations.
 
Specifically, this course will focus on learning the protocols and techniques needed to establish specifications required to support all levels of development. Attendees are actively engaged through the use of workshops and in-depth discussion, including exercises on writing and revising specifications and the stability data required to support these specifications.

Course Description

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. 

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