PharmExpert: Advanced Analytical Practices for the Pharmaceutical Industry: Case Studies
Dates
Past dates: June 2024
Format
Online
Course Objectives
The course aims to provide up-to-date knowledge on the validation of equipment and instruments used for analytical work in pharmaceutical R&D and quality control laboratories, leachables and extractables testing, the toxicological assessment of leachables and extractables analysis results, the review of DMF dossier components from an analytical perspective, method transfer, manufacturing site changes, transition to more sensitive methods, disregard limits in impurity testing, new applications of statistics in pharmaceutical analysis, nitrosamines and analytical methods for their determination, and the toxicological assessment of nitrosamines.
Who Can Attend
- Pharmacists
- Chemists
- Chemical engineers
- Pharmacy students
- Chemistry students
- Chemical engineering students
Course Content
- Equipment and instrument validation
- Leachables and extractables testing (instruction and practical exercises)
- Toxicological assessment of leachables and extractables analysis results
- New applications of statistics in pharmaceutical analysis
- DMF dossier components from an analytical perspective
- Method transfer, manufacturing site changes, transition to more sensitive methods, and disregard limits in impurity testing
- QbD assessments from an analytical perspective
- Nitrosamines and analytical methods for their determination
- Toxicological assessment of nitrosamines
Duration and Capacity
Duration: 18 hours
Capacity: 50 participants
Course Coordinator
- Prof. Dr. Halil İbrahim Ulusoy
- Assoc. Prof. Dr. Songül Ulusoy
- Prof. Dr. Belma Gümüşel
Instructors
- Prof. Dr. Halil İbrahim Ulusoy
- Assoc. Prof. Dr. Songül Ulusoy
- Prof. Dr. Belma Gümüşel