Medical Device Validation

Commissioning Qualification and Validation the Concept of CQV – Part 3

This course is part of a complete program on Commissioning, Qualification, and Validation, which includes the following individual courses intended for completion in the order listed, overview and risk-based impact assessment, risk analysis and management and qualification validation and supporting quality. This is the third course in this program and introduces key concepts around qualification, validation, and supporting quality assurance programs. You should take this course after taking the Risk Analysis and Management course.

CEU Credits: 0.1
Course Code: ELM-183
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Learning Objectives
Who Should Take This Program?
Glossary
Commissioning
Qualification
Verification - ASTM E2500 Approach
Review Activity #1
Installation Qualification (IQ)
Operational Qualification (OQ)
OQ and Commissioning
Performance Qualification (PQ)
Equipment / System Acceptance and Release
Process Performance Qualification – Part 1
Process Performance Qualification – Part 2
Review Activity #1
Analytical Method Validation – AMV
Process Validation – PV
Cleaning Validation - CV
Review Activity #1
Change Control
Deviation
Standard Operating Procedures (SOPs)
Training
Calibration
Preventative Maintenance
Re-qualification
Review Activity #1

Conclusion

Final Assessment

Certification

Author

Joginder Mittal

Manager - Quality Compliance Glatt Pharma Engineering

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