Qualification and Validation workshop
In-person/ Virtual
8 Sessions
Suggested alternatives:
Who Should Attend?
YOU MUST HAVE 6 months OF EXPERIENCE IN ENGINEERING, QUALITY ASSURANCE or PRODUCTION
Course Objective:
Upon completion of this course, you will be able to:
- Define Validation Master Plans
- Describe the Impact/Risk Assessment
- Prepare IQ/OQ/PQ Protocols
- Execute Protocols
- Write Protocol Summary Reports
- Describe the Quality Systems Necessary to Support Validation
Course Topics:
- Validation Life Cycle ( FDA/ ISPE)
- Qualification of HVAC System and Thermal Mapping
- Qualification of Autoclaves and pure steam
- Qualification of Ovens and Tunnels
- Qualification of Compressed air systems.
- Process Validation
- Cleaning Validation
- Validation of Computerized Systems (CSV)
- Qualification of Water System
Number of Sessions :
8 Sessions
Instructor:
SPEAKER
Mohamed Saad Mohamed
Pharma Consultant, VALOR GM
20+ years working in pharmaceutical field, working for different pharmaceutical drug manufacturers, VALOR GM.
20+ years working in pharmaceutical field, working for different pharmaceutical drug manufacturers, VALOR GM.
SPEAKER
Dr. Ahmed Badran
Quality Assurance . validation- CSV supervisor
15+ years Experience in Qualification in pharmaceuticals
SPEAKER
Osama Adel
Technical Manager
Osama AdelTechnical Manager
15+ years Experience in Qualification in Qualification service provider
Speaker
Mahmoud Hanafy
Validation and Calibration Section Head
9+ years' experience in Validation and Calibration in pharmaceuticals
15+ years Experience in Qualification in Qualification service provider
Speaker
Validation and Calibration Section Head
Mahmoud Hanafy
Validation and Calibration Section Head
9+ years' experience in Validation and Calibration in pharmaceuticals
Specifications for Qualification and Validation workshop
| Attendance type | In-person/ Virtual or E- Learning |
| Minimum Experience | 1 |
| Number of Sessions | 8 |
| Accreditation | VALOR |