Executive Development Programme in Quality Control in Pharmaceuticals: Dissolution Testing

This course is designed for pharmaceutical quality control managers, QC supervisors, and laboratory technicians aiming to enhance their expertise in dissolution testing. Participants will gain a deep understanding of dissolution testing methodologies, regulatory requirements, and best practices to ensure drug product quality compliance.

Upon completion, attendees will be proficient in conducting and interpreting dissolution test results, capable of implementing quality control strategies, and equipped to address regulatory inspections effectively.

1. 1. Introduction to Quality Control in Pharmaceuticals: Learners will study the basics of quality control in the pharmaceutical industry and gain an understanding of its importance. They will learn how to apply quality control principles to ensure drug product quality and consistency.
2. 2. Fundamentals of Dissolution Testing: This module covers the principles of dissolution testing, including factors affecting dissolution rates and the significance of dissolution profiles in drug quality assessment. Learners will gain practical skills in setting up and conducting dissolution tests.
3. 3. Method Development and Validation for Dissolution Testing: Learners will delve into the development and validation of dissolution testing methods. They will understand the criteria for method validation and how to optimize dissolution test conditions for accurate and reliable results.
4. 4. Analytical Techniques in Dissolution Testing: This module focuses on the use of analytical techniques in dissolution testing, such as UV-Vis spectroscopy, infrared spectroscopy, and HPLC. Learners will learn how to apply these techniques to analyze dissolution samples and interpret results.
5. 5. Regulatory Requirements and Compliance in Dissolution Testing: Learners will explore the regulatory frameworks governing dissolution testing in the pharmaceutical industry. They will gain knowledge on how to ensure compliance with regulatory standards and guidelines.
6. 6. Advanced Dissolution Testing Methods: This module covers advanced dissolution testing methods, including in vitro/in vivo correlation studies and advanced dissolution models. Learners will understand how to apply these methods to predict in vivo performance and improve drug product design.
7. 7. Troubleshooting Common Dissolution Testing Issues: This module addresses common challenges and troubleshooting techniques in dissolution testing. Learners will learn how to identify and resolve issues related to sample handling, equipment calibration, and data interpretation.
8. 8. Quality Risk Management in Dissolution Testing: Learners will study the principles of quality risk management (QRM) and apply them to dissolution testing processes. They will learn how to identify, assess, and mitigate risks to ensure process reliability and product quality.
9. 9. Case Studies in Dissolution Testing: This module includes real-world case studies of dissolution testing applications in the pharmaceutical industry. Learners will analyze case studies to understand best practices and learn from successful and unsuccessful approaches.
10. 10. Continuous Improvement in Dissolution Testing: This final module focuses on continuous improvement strategies for dissolution testing processes. Learners will learn how to implement improvement initiatives and maintain high standards of quality control in pharmaceutical manufacturing.