Workshop Overview

This is an International Hands-On Online Practical Training Workshop focused on Quality by Design (QbD). The workshop aims to provide practical implementation of QbD tools and tactics, along with Six Sigma methodologies, in formulation, process, and analytical methods development.

The workshop will cover key areas such as drug-excipient compatibility testing. It is designed and developed by Shivang Chaudhary.

Participants will gain insights into various aspects of QbD implementation, enhancing their skills in pharmaceutical development and analysis.

Event Details and Schedule

The workshop is scheduled to take place from August 5th to August 8th, 2025. This is a 4-day intensive training program.

The workshop will cover Analytical Quality by Design (AQbD) principles, incorporating Design of Experiments (DoE), MODR, and Statistical Quality Control (SQC).

Early bird registration is available until July 19th, 2025, offering a discounted rate for those who register early.

Key Topics and Case Studies

The workshop will feature model case studies based on AQbD for various analytical methods. These include assay method development by HPLC, impurity method development by UPLC/LC-MS, and dissolution method development with iViVC.

Further topics include residual solvent method development by GC, water content method development by KF, polymorphic form analysis by DSC & pXRD, and particle size determination (PSD) by LLD.

Stability studies, data modeling, and shelf-life extrapolation will also be covered, providing a comprehensive understanding of analytical method development.

Hands-On Training and Software

Participants will engage in hands-on advanced practical training with 101 case studies of DoE-AQbD. This training will utilize Design-Expert software.

The workshop will also cover SPC L6σ using Minitab software, providing practical experience with statistical analysis tools.

This practical approach ensures participants can apply the learned concepts effectively in their work.

Course Materials and Resources

Comprehensive course materials will be provided, including AQbD models (presentation handouts). Risk & Impact Assessment Templates will also be included.

Design-Expert DoE MODR Design Templates, Minitab L6σ SPC SQC Charts Templates, and AQbD, FQbD, DoE, SPC & SQC Master Guides will be provided.

Additional resources include Blend & Content Uniformity Analysis Sheets, Dissolution Modeling & Profile Comparison Sheets, IVIVC Correlation & Prediction Sheets, Scale-Up Factors Calculators sheets, Stability & Shelf Life Extrapolation Templates, and a Project Management Scheduler Template.

Registration and Contact Information

The last date for Early Bird Discounted Registration is July 19th, 2025. Interested participants are encouraged to register before this date to avail the discount.

For registration inquiries, you can contact +91 9904474045 via WhatsApp. Alternatively, you can email qbdexpert@gmail.com.

Don't miss this opportunity to enhance your skills in Quality by Design and analytical method development.