Analysis and Testing

About This eLearning

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