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.
