Stream: Quality Control, Analytics & Product Release
The regulatory backbone of a QC laboratory: quality systems, electronic records under 21 CFR Part 11, assay qualification and validation, compendial method verification, and the data review workflow that stands behind every release decision.
Learning Objectives:
- Describe the regulatory framework governing a GMP quality control laboratory
- Apply 21 CFR Part 11 requirements to electronic records and signatures
- Distinguish assay qualification, validation and verification, and select the correct approach
- Execute a compliant data review and approval workflow
Modules:
- Introduction to Quality Control
- Quality Management Systems
- 21 CFR Part 11
- Assay Qualification and Validation
- Assay Verification of Compendial Methods
- Data Review and Approval Workflow
EST. COMPLETION 2.25 HRS - E-Learning format