This continually updated course covers the broad range of operations involved in the development and commercializing of a New Chemical Entity (NCE) and its associated Drug Product. Topics will include stability, impurity profiles, polymorphism, compendial vs. non-compendial testing, and the use of reference standards.
Participants will also understand the specifications needed to meet current FDA regulatory requirements and ICH guidelines with particular emphasis on QbD with selected case studies and discussions of how Design Space and Design of Experiments (DOE) can lead to better understanding of the product, as well as setting of meaningful specifications throughout the product lifecycle.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This course is designed for those engaged in R&D, Regulatory Affairs, Quality Assurance and Quality Control who are responsible for activities in the development and manufacture of Active Pharmaceutical Ingredient (API) and Drug Products. Personnel who desire an in-depth knowledge of the critical role of specifications and the importance of USP compendial requirements, FDA regulations and ICH guidelines, as well as the relationship between ICH Guidelines and the Common Technical Document (CTD) will find this course of great value.
This comprehensive three-day course is also beneficial to R&D personnel responsible for the use of specifications in conducting Quality by Design (QbD) development of both API and Drug Products.
The course is also of interest to personnel in all departments who participate in the support of manufacture and release of APIs and Drug Products. This includes development personnel in preparing API and Drug Product under cGMP protocols for clinical and non-clinical use, as well as analytical chemists involved with stability testing, assays, methods development and drug release.
This course provides a comprehensive presentation of the role of specifications throughout the product lifecycle as described in ICH Q6A, as well as the relevancy of Q8, Q9, Q10, and Q11 to the setting of appropriate and meaningful specifications.
This course will focus on the criticality of specifications for API, raw materials (starting materials for both API and Drug Product), intermediates, drug products, excipients and placebos. Course curriculum will address FDA guidances and ICH guidelines and the requirements for submitting the CTD.
Upon completion of this course, attendees will have a clear understanding of the many factors involved in setting specifications to meet regulatory agency expectations. Attendees are actively engaged throughout the seminar.