Training Modules

Training Module-2 (ADL related)
(Duration-45 Days) (Theoretical & Practical/Hands-on)

1. Analytical Method Development Training (HPLC/GCHS)
2. Analytical Method Validation as per Regulatory guidelines (ICH, ANVISA etc.) (HPLC/GCHS)
3. Stress Study / Stability Study
4. Pharmaceutical Sample Analysis (Raw Material/Key Starting Material, Intermediates and Drug Substances)
5. Calibration/ Verification of Analytical Instruments
6. cGLP (Good Laboratory Practices) Trainings as below,
SOP (Standard Operating Procedure) preparation
Specification and Method of Analysis preparation
Volumetric Solution and Reagent Preparation
Standard and Sample preparation
Pipetting techniques
Standard management (Primary Reference Standard, Working Standard and Impurity Standard)
QMS (Quality management system)
7. Guidance of different Pharmacopeia like USP, EP, BP, IP, JP and ICH Guidelines
8. Training on 21 CFR Part-11
Note: Practical Training on: HPLC, GC, GCHS for Method Development and Method Validation

Aashtha Training Center

Certificate Course is benefited to get get Job in Quality Control (QC) department and Analytical Development Lab (ADL) in Pharmaceutical Industries & Chemical industries.

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