Analysis and Testing

This self-paced learning course provides comprehensive instruction on analysis and testing in pharmaceutical manufacturing. This course utilizes real-world scenarios, embedded video and audio content to instruct on the practical application of these requirements. Engaging knowledge checks are provided throughout each module, and the course concludes with a final competency assessment.

The program contains four modules with an approximate course completion time of 6 hours.*

Module 1: Prerequisite Program (0.5 hours)

Provides basic and fundamental requirements of the quality control laboratory. At the end of this module, you will be able to:

• Understand the eight stages of the data lifecycle
• Explain the proper use of laboratory notebooks
• Understand the crucial role of quality in the validation and analysis of product design
• Explain quality control’s place in the manufacturing lifecycle

Module 2: Introductory Topics (1.5 hours)

Provides key information on analysis and testing, particularly in the quality control laboratory. At the end of this module, you will understand:

• Analytical chemistry and the quality control laboratory
• Analysis and testing fundamentals
• Equipment and instruments
• Materials and supplies
• Analytical balances

Module 3: Intermediate Topics (2 hours)

Provides a deeper dive into laboratory systems. At the end of this module, you will be able to explain:

• Laboratory systems
• USP, FDA, and ICH requirements and guidelines
• Key laboratory systems

Module 4: Advanced Topics (2 hours)

Provides information on stability and stability programs, method validation versus verification, and conducting laboratory investigations. At the end of this program, you will understand:

• Stability and stability programs
• Method validation and verification
• How to conduct a laboratory investigation