by Dr. Peter Nagi

Attendance Type: Client Site
Duration: 4 Sessions

Attendance Type: Client Site
Duration: 3 Sessions

Client Site
by Dr. Mohamed Saad

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)

Course Topics: (7 Modules)
1. Quality Systems (2 Sessions)
2. Laboratory System (2 Sessions)
3. Infrastructure: Facilities, Utilities, Equipment (2 Sessions)
4. Materials management (1 Sessions)
5. Manufacturing Systems (1 Sessions)
6. Filling, Packaging, Labeling (1 Sessions)
7. Product Development (1 Sessions)

Number of Sessions:
10 Sessions

Corporate training
3 session

Client Site

السلوك الجيد في المناطق العقيمة
Client Site

Client Site

In-Person/Virtual

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.

Attendance Type: Client Site
Duration: 5 Sessions

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

: مواضيع الدورة
فهم قواعد التصنيع الجيد -
دخوا المناطق الانتاجية والنظافة الشخصية -
المخازن والمواد -
عمليات التصنيع -
عمليات التعبئة التغليف -
الوثائق وقواعد التسجيل الجيد -

: عدد النحاضرات
6 محاضرات

1 Sessions

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

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