Mysore Analytical Services

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Module 2 - ADL

Overview

Training Module 2: Analytical Method Development & Validation (ADL)

This 45-day training program focuses on developing and validating analytical methods in alignment with global regulatory standards. Designed for analysts, QA/QC professionals, and students, the course provides in-depth, hands-on training with HPLC and GC systems, emphasizing accuracy, reproducibility, and regulatory compliance.

Duration: 45 Days | Mode: Theoretical & Practical (Hands-On)

Core Training Areas

Method Development (HPLC/GC)

Learn to develop robust analytical methods using High Performance Liquid Chromatography and Gas Chromatography techniques.

Method Validation as per Regulatory Guidelines

Understand how to validate methods as per ICH, SANTE, and other regulatory protocols for parameters like accuracy, precision, linearity, robustness, and stability.

Hands-on training in the analysis of:

  • Raw materials
  • Key starting materials
  • Intermediates
  • Drug substances (pharmaceutical)
  • Food samples

Participants will gain experience in:

  • Calibration of HPLC and GC systems
  • Verification procedures for analytical accuracy
  • Ensuring data traceability and system suitability

The training includes detailed instruction in:

  • SOP (Standard Operating Procedure) preparation
  • Specification & Method of Analysis drafting
  • Volumetric solutions & reagent preparation
  • Standard & sample preparation techniques
  • Pipetting skills
  • Management of standards (Primary Reference, Working, and Impurity Standards)
  • QMS (Quality Management System) and lab safety protocols

SANTE Guidelines

For pesticide residues and food safety standards

ICH Guidelines

For analytical validation, stability studies

  • Mock interviews aligned with industry expectations
  • Presentation skills for technical and lab report communication
  • HPLC – Method development, optimization & troubleshooting
  • GC – Validation and analytical performance evaluation

Outcome

Upon successful completion, participants will have hands-on expertise in method development and validation processes, a thorough understanding of regulatory guidelines, and the confidence to step into QC/ADL roles in pharma, food, and chemical industries.