Information détaillée concernant le cours
Titre | Validation of analytical methods, regulatory and practical aspects !! FULL!! |
Dates | 02.06.21 AM; 04.06.21 AM + PM; 08.06.21PM; 11.06.21 AM + PM; 15.06.21 self working; 18.06.21 AM + PM |
Lang | Workshop language is English |
Organisateur(s)/trice(s) | Prof. Serge Rudaz, UNIGE Dr Julien Boccard, UNIGE |
Intervenant-e-s | Prof. Serge Rudaz, UNIGE Dr Julien Boccard, UNIGE Dr Jean-Marc Roussel, Independant Consultant, Analytical Methods Development and Validation |
Description |
The demonstration of the ability of an analytical method to quantify is of great importance to ensure quality, safety and efficacy of pharmaceuticals. Consequently, before an analytical method can be implemented for routine use, it must first be validated to demonstrate that it is suitable for its intended purpose.
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Programme |
02.06.21 AM (JMR) 3hours of teaching:
1. Objective of the Validation (1 hour)
2. Documentation and regulatory bodies (1 hour)
3. Quality Assurance and Traceability (1 hour)
04.06.21 AM (SR) 3 hours of teaching:
4A. Selectivity and Robustness / 4B. Range (1 hour)
4C. Quantitative aspects (2 hours)
1hour reading : ICH - FDA Drugs
04.06.21 PM (JB): 3 hours of STAT
5. Variance and Anova (2 hours of practice)
6A. Formulation pharmaceutique : exemple1 - Part 1 ANOVA (1 hour of practice)
08.06.21 PM (SR) 3 hours of STAT
7. Profils d'exactitude Cours théorique (2 hours of teaching/practice)
6B. Formulation pharmaceutique : exemple (Suite) (1 hour of practice)
11.06.21 AM (SR/JB) 3 hours of teaching and STAT
8. FDA / EMA Biological Fluids (2 hours of teaching)
10A. The Methadone example Part 1 (1 hours of practice)
11.06.21 PM: 2 hours
10B. Alternative Calibration (2 hours)
1 hour of reading : FDA /EMA/ICH10
15.06.21 2 hours of Self Working (STAT)
12. The caffeine/Theophiline/theobromine example
Validation practice STAT incl Correction
1 hour of reading: Uncertainty
18.06.21 AM (JMR) 3 hours of teaching:
Generality of Uncertainty (1 hour)
Method uncertainty (From Validation or others) (1 hour)
Decision with Method uncertainty (1 hour)
18.06.21 PM (SR/JB): 3 hours (STAT)
12. The caffeine/Theophiline/theobromine example (2 hours of practice)
Discussion and Conclusion (1 hour)
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Lieu |
Université de Genève, CMU, room TBD |
Crédits | 4 |
Information | |
Places | 12 |
Délai d'inscription | 07.04.2021 |