Designed for QC analysts, laboratory technicians, research scientists and biomanufacturing professionals seeking to build foundational knowledge of quality control regulations, analytical methods, testing practices and out-of-specification investigations in a GMP-regulated environment.
Learning Objectives:
- Understand QC regulatory requirements and best practices applicable to GMP-regulated biomanufacturing environments.
- Explain fundamental analytical science principles and their application to quality control testing.
- Identify and apply key principles of out-of-specification (OOS) investigations, including documentation, root cause analysis and corrective actions.
- Describe common cell counting methods and their applications, limitations and importance in assessing cell quality and viability.
- Understand molecular analytical methods used in quality control, including their principles, applications and role in ensuring product quality and consistency.
Included courses:
- Quality Control Regulations and Best Practices
- Analytical Science and Technology Basics for QC
- Out-of-Specification Investigations
- Cell Counting Methods
- Molecular Methods
EST. COMPLETION 8 HRS - E-Learning format