Training Topics
Introduction of the Pharmaceutical Industries various functions
Introduction of the ICH Guidelines
Theoretical Sessions on the Various chromatographic Techniques, Wet lab analysis (Chemical analysis)
Training on 21 CFR Part 11
Analytical Method Validations as per ICH Q2 (R1)
Stability studies as per ICH Q1
Introduction of the Pharmaceutical Industries various functions
Introduction of the ICH Guidelines
Theoretical Sessions on the Various chromatographic Techniques, Wet lab analysis (Chemical analysis)
Training on 21 CFR Part 11
Analytical Method Validations as per ICH Q2 (R1)
Stability studies as per ICH Q1
Elemental Impurities as per ICH Q3D (Theoretical)
Specification Preparation as per ICH Q6
Method Development and Method Optimisation Tools
Organic Impurities, Inorganic impurities, Genotoxic Impurities evaluation
Particle size Analysis by Laser diffraction technique (Theoretical)
Residual Solvents as per ICH Q3C
Elemental Impurities as per ICH Q3D (Theoretical)
Specification Preparation as per ICH Q6
Method Development and Method Optimisation Tools
Organic Impurities, Inorganic impurities, Genotoxic Impurities evaluation
Particle size Analysis by Laser diffraction technique (Theoretical)
Residual Solvents as per ICH Q3C
Hand on/Practical sessions
HPLC (High Pressure Liquid Chromatography)
GC (Gas Chromatography)
GC-HS (Gas Chromatography with Head Space)
UV Spectrophotometer
Karl Fisher (Water Content)
Auto titrator (Potentiometer)
Melting Point Apparatus
pH Meter
Hot air oven
Weighing Balance
Hand on/Practical sessions
HPLC (High Pressure Liquid Chromatography)
GC (Gas Chromatography)
GC-HS (Gas Chromatography with Head Space)
UV Spectrophotometer
Karl Fisher (Water Content)
Auto titrator (Potentiometer)
Melting Point Apparatus
pH Meter
Hot air oven
Weighing Balance
