Commissioning Qualification and Validation the Concept of CQV – Part 3
Description:
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.
Curriculum for this course:
Program Overview
| Learning Objectives | 1 min 10 secs |
| Who Should Take This Program? | 1 min 01 secs |
| Glossary | 1 min 21 secs |
Module 1: ISPE vs ASTM E2500
| Commissioning | 1 min 05 sec |
| Qualification | 1 min 10 secs |
| Verification – ASTM E2500 Approach | 1 min 05 secs |
| Review Activity #1 | 1 min |
Module 2: Qualification
| Installation Qualification (IQ) | 1 min 12 secs |
| Operational Qualification (OQ) | 1 mins 29 secs |
| OQ and Commissioning | 1 min 21 secs |
| Performance Qualification (PQ) | 1 min 25 secs |
| Equipment / System Acceptance and Release | 1 min 10 secs |
| Process Performance Qualification – Part 1 | 1 min 09 secs |
| Process Performance Qualification – Part 2 | 1 min 30 secs |
| Review Activity #1 | 1 min |
Module 3: Validation
| Analytical Method Validation – AMV | 58 secs |
| Process Validation – PV | 1 min 20 secs |
| Cleaning Validation – CV | 1 min 01secs |
| Review Activity #1 | 1 min |
Module 4: Supporting Quality Assurance Program
| Change Control | 1 min 19 secs |
| Deviation | 1 min 02 secs |
| Standard Operating Procedures (SOPs) | 1 min 10 secs |
| Training | 1 min 10 secs |
| Calibration | 1 min 02 secs |
| Preventative Maintenance | 1 min 15 secs |
| Re-qualification | 1 min 22 secs |
| Review Activity #1 | 1 min |
Conclusion
Final Assessment
Certification
Author:
General Info:
-
CEU Credits: 0.1 -
Course code: ELM-183 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
This program is a must do for anyone involved in CQV, it really explains the whole process from start to finish.
This is now mandatory training for anyone working in validation in our company.
Related courses:
Commissioning Qualification and Validation the Concept of CQV – Part 1
Commissioning Qualification and Validation the Concept of CQV – Part 2
Risk Based Equipment Qualification
Computer System Validation: Periodic Review Strategies Part 1
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Computer System Validation – The Regulated Software Life Cycle
Combination Products (Drugs, Devices and Biologics) – Part 1
Combination Products (Drugs, Devices and Biologics) – Part 2
Combination Products (Drugs, Devices and Biologics) – Part 3
Talk to us
Find out how we can help you bring your life science training to the next level.