Analytical Quality by Design (AQbD)

Course Duration: 32 Hours of Comprehensive Learning

Mode of Learning:

Choose the learning style that best fits your schedule and preferences:

Online Instructor-Led Training – Learn in real time with live expert-led sessions.
Online Self-Paced Learning – Study anytime, anywhere with flexible recorded modules.
Onsite/Classroom Training – Experience in-person, hands-on learning guided by certified trainers.

What’s Included in the Training Program:

Our industry-leading Training Program is designed to provide a complete learning experience through a perfect blend of theory and practical exposure. Here’s what you’ll get:

Live, Instructor-Led Online Training Sessions
Hands-on Lab Exercises
Certified and Experienced Trainers
Post-Training Support & Mentorship
Comprehensive Learning Resources including eBooks, guides, and reference materials.
Real-World Case Studies & Application Scenarios
Networking Opportunities
Group Projects and Collaborative Learning Activities
Best Practices and Industry Insights.
Access to Recorded Sessions (available for online learners, based on client permissions).
Follow-up Review Sessions.
Tool Demonstrations and Guided Walkthroughs

This training helps you gain the knowledge and hands-on experience needed to advance your career in today’s competitive IT landscape.

Course Content

Introduction to AQbD and its Regulatory Framework

Evolution from QbD to AQbD
ICH Guidelines (Q8–Q14) and Regulatory Expectations
Importance of AQbD in Analytical Method Lifecycle

Analytical Quality by Design (AQbD)

Course Duration: 32 Hours of Comprehensive Learning

Mode of Learning:

What’s Included in the Training Program:

Course Content

Introduction to AQbD and its Regulatory Framework

Evolution from QbD to AQbD

ICH Guidelines (Q8–Q14) and Regulatory Expectations

Importance of AQbD in Analytical Method Lifecycle

Key Concepts and Terminologies

Analytical Target Profile (ATP)

Critical Method Parameters (CMPs) and Critical Method Attributes (CMAs)

Quality Risk Management (QRM) principles in AQbD

Design Space and Method Control Strategy

Method Understanding and Risk Assessment

Identification of Critical Quality Attributes (CQAs)

Linking CQAs to Analytical Method Variables

Risk Assessment Tools: Ishikawa Diagram, FMEA, and Risk Ranking

Defining the Method Design Space

Design of Experiments (DoE) for Analytical Methods

Overview of Experimental Design Approaches

Full and Fractional Factorial Designs

Screening vs Optimization Experiments

Practical Demonstration using Minitab/JMP

Statistical Analysis and Method Optimization

Interpretation of Main Effects and Interaction Plots

Regression Models and ANOVA in Method Optimization

Building Predictive Models and Design Space Definition

Establishing Method Control Strategy

Control of Method Variables

Lifecycle Management of Analytical Methods

Documentation and Reporting Requirements

Advanced AQbD Implementation Strategy

Integration of AQbD into Product Development Lifecycle

Linkage between Formulation QbD and Analytical QbD

Risk-Based Method Validation and Robustness Assessment

Method Development Case Studies

Case Study 1: Development of HPLC Method using AQbD

Case Study 2: AQbD Approach for Dissolution Method Development

Case Study 3: AQbD in Analytical Method Transfer and Validation

Software Tools and Practical Insights

Use of Minitab / JMP / Design Expert for AQbD Studies

Statistical Model Validation and Design Space Visualization

Control Strategy Reporting and AQbD Dossier Preparation

Regulatory Expectations and Industry Best Practice

ICH Q14 & Q2(R2) – Analytical Method Development and Validation Framework

Common Gaps and Audit Observations in AQbD Implementation

Practical Compliance Insights from Industry and FDA Perspectives

Group Discussion & Q&A

Participant-specific challenges in Analytical Method Development

Discussion on real-world implementation barriers and solutions

Course Includes:

Company

Support

Contacts