"Regulation of Biologics" Training CoursesI have given 3 different training courses on Regulation of Biologics. It depends on the client and their needs. View the 3 different courses I have given below ... I can give a 1 day, 2 day or 3 day training course at a location of your choice. The 1 day training course costs $2000.00 Canadian (plus 7% GST). The 2 day training course costs $3800.00 Canadian (plus 7% GST). The 3 day training course costs $5500 Canadian (plus 7% GST). Travel and accomodation are additional. These prices include up to 10 manuals. The 1 day training course covers: Regulatory Process at Health Canada, Clinical Trial Requirements, New Drug Submission Format, Common Application Screening Deficiencies, Chemistry and Manufacturing Requirements and Common deficiencies, Inspection (On Site Evaluation) Process, Common Exit Notice (FDA 483 equivalent) Observations, and Lot Release Program. The 2 day training course covers all of the information covered in Day 1 plus the following: Production Process for Biologics, Facility Design Considerations, Validation and Good Manufacturing Practice (GMP). The 3 day training course covers all of the information covered in Day 1 and 2 plus the following: more details on Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and the On Site Evaluation Process as well as application of GMP to Clinical Trials. Return to top of page or to home page. |