Course Topics:
I. Organization-Wide Planning and Deployment
II. Organizational Process Management and Measures
III. Team Management
IV. Define
V. Measure
VI. Analyze
VII. Improve
VIII. Control
IX. Design for Six Sigma (DFSS) Framework and Methodologies

Number of Sessions :
20 Sessions

With MINI TAB
Course Topics:
- Descriptive stats
- Distribution& sampling
- Statistical Process control
- Infrential statistics

Number of Sessions :
4 sessions

Features:
-two electricity sockets in the interior.
-Equipped with air fan with controlling the air speed.
-External: made of high-quality 304 stainless steel.
-Anti-bacterial glass manual door
-Ultraviolet lamp (UV) for sterilization.
-Interior illumination (fluorescent lamp).
-Applied with TWO HEPA filter.( 99,999% Efficiency for
Particles ≥0,3µm ( H14 class according to EN 1822))
-Interior space made of high-quality 304 stainless steel.
- Working Table : 304 Stainless Steel
-Airflow Speed Control :Microprocessor Control System
with LED Display and Automatic Speed Compensation for
increasing Filter Resistance
-Light : High Efficiency, Low Voltage
-Air blower for generating flowing air with pressure
( High capacity motor/blower system )
- 70% air recirculated; 30% exhausted from a common
plenum to the room
- Audible and visual alarm system for at least compromised
airflow
MADE IN EGYPT

Attendance Type: Inperson/Virtual

Course Topics
- Facility Design& Gowning Procedure
- Receipt of materials
- Sampling processes
- Material storage, identification, and rotation
- Dispensing Process
- Salvaged/returned goods and destruction.
- Traceability and sourcing
- Thrmal mapping
- Shipping and distribution (GDP)
- Documentaions
- Internal Auditing

Number of Sessions:
6 Sessions

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
Sterile Facility& Services.
Sterile Process& Equipment
Sterile Products Formulation
Sterile Products Quality Approach

Number of Sessions :
5 Sessions

Instructor:
Dr. Shady Nabil
Global Pharmaceutical industries
20+ years of Sterile Manufacturing experience.

Eman sayed
Quality Assurance Manager
+20 years experience in the quality assurance field, certified CPGP -ASQ.


Dr. Akram Bashir
Branch Manager of Nawah Scientific and the formulation Lab.
15+ years working in pharmaceutical R&D field.

Course Topics
Day 1: Operation

Receiving, Dispatch, Maintenance , Physical count, Location system, identification , Infrastructure , Recall, Falsified , Return

Day 2: Operation

Cleaning, Trucks monitoring and maintenance, Fire fighting, Temperature monitoring , Power off recovery, FEFO, Printing process, Temperature monitoring , Power off recovery, FEFO, Printing process, Invoicing

Day 3: Quality Management System

SMF , JD, Organization chart, Documented information, Risk management , Deviation, Complaint

Day 4: Quality Management System

Physical security, Pest control, Hazard control, Training, Management review, CAPA

Day 5: Quality Management System

Self inspection , Calibration , Contracts, Validation warehouse, cold room, printing, truck.

MIC – Taiwan
Modwel : 98716
MIC 98716 SERIES PH METER
APPLICATION
Industial: Check water conditioning plants, cooling
towers, planting, finishing operations, food
processing water testing (for HACCP compliance),
printing, chemical industries, water/wastewater
treatment.
Environmental/Agricultural: Use in ecology studies,
aquariums, hydroponics.
Laboratory: Food processing, environmental studies,
chemical labs, titration, quality assurance testing,

PH, meter Bench NEW
CHINA

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

Client Site