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Computerized Systems Validation Session
222.00 222.00 222.0 USD
Attendance Type: Client Site
Duration: 1Session
by Dr. Ahmed Badran
Data Integrity & Data Governance
0.00 0.0 USD
Attendance Type: Client Site
Duration: 3 Session
Course Agenda:
- Session 1: Data integrity & Data governance awareness
- Session 2: Data integrity risk assessment
- Session 3: Implementation
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Risk Management Workshop- Client Site
0.00 0.0 USD
Attendance Type: Client Site
No. Of Sessions: According to Number of topics chosen from Below topics

Course Topics:
Risk Management approach andTools
Material Handling Risk Assessment
Production lines risk assessments
Utilities risk assessment.
Materials and personelle flow risk
Environmental monitoring ( EM) risk assessment
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Pharmaceutical Facility
0.00 0.0 USD
1 Sessions
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Good Engineering Practices (GEP) - Client Site
0.00 0.0 USD
12 Sessions
-Validation Life Cycle-Commissioning& Qualification
-Factory Zones& Facility Design
-Clean room Standard& HVAC Components
-Qualification of HVAC System
-Water Systems- Purified
-Qualification of water systems
-Equipment& Automated and Computerized Systems
-Thermal Mapping& Qualification of Compressed air systems
-Autoclave qualification& Pure Steam
-Tunnels and ovens Qualification
-Process Validation
-Cleaning Validation
Quality Systems Course - Client Site
0.00 0.0 USD
Attendance Type: Client Site
Duration: 7 Sessions
-Quality management system(QMS)
-Audits and self-inspections
-Risk management
-Data Integrity and Data Governance
-Change control and management
-Investigations and corrective and preventive action(CAPA)
-Product quality complaints vs. adverse event Reports
-Documents and records management
-Product trend requirements PQR
-Supplier and contractor quality management.
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Impurities in Biologicals Products
0.00 0.0 USD
In-Person/Virtual
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Advanced Process Validation - Client Site
0.00 0.0 USD
Life Cycle Approach of Process Validation

Workshop : solid product ( protocol design , excusion, and with minitab application of capability and control charts)

Workshop : Parentral product ( protocol design , excusion, and with minitab application of capability and control charts)
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Statistics and Statistical Analysis Workshop
0.00 0.0 USD
Attendance Type: Client Site
Duration: 4 Sessions
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Qualification of Autoclave& Pure Steam
0.00 0.0 USD
Attendance Type: Client site
Duration: 1 Session
by Eng. Osama Adel
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Commissioning and Qualification
0.00 0.0 USD
Attendance Type: Client Site
Duration: 1Session
by Dr. Mohamed Saad
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Quality systems
0.00 0.0 USD
Attendance Type: Client Site
Duration: 5 Sessions
By Dr. Peter Nagy
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Sampling / ISO 2859 Training
0.00 0.0 USD
Attendance type: Client site
Duration: 1 session
By Dr. Omar Adel
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Process Validation
0.00 0.0 USD
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Documentation and GDP
0.00 0.0 USD
Attendance Type: Client Site

Agenda:
- Documentation and GMP
- Document control
- Record Management and control
- Data Storage and back up
- Good Recording Practices
- ALCOA/ ALCOA+
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Distilled Water and Steam Systems
0.00 0.0 USD
Attendance Type: Client Site
Duration: 1 Session
by Dr. Ahmed Fouad
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Purified Water Systems
0.00 0.0 USD
Attendance Type: Client Site
Duration: 1 Session
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Qualification of Oven & Compressed air
0.00 0.0 USD
Attendance Type: Client Site
Duration: 1 Session
by Eng. Osama Adel