MODULE 1
GMP-compliant pharmaceutical facility layout and cleanroom design.
OUR TALENT INSTRUCTORS:
DR/ MAHA IDRIS
A Pharmaceutical Professional With Over 33 Years Of Experience In Regulatory Inspection, Licensing, And Quality Systems.
Served As An Inspector For 8 Years, Followed By 23 Years As Head Of Inspection Department And 2 Years As Head Of Licensing Department. Contributed To The Licensing Of Approximately 75% Of Pharmaceutical, Cosmetics, And Medical Device Manufacturing Facilities In Egypt.
Also Served As A Consultant For Several Pharmaceutical, Cosmetics, And Medical Device Manufacturing Facilities Under Establishment, Supporting Regulatory Compliance And Inspection Readiness. Participated, In Collaboration With The World Health Organization (WHO), In Updating HVAC Guidelines.
DR/ REHAM MAGDY
A Pharmaceutical Professional With Over 33 Years Of Experience In Regulatory Inspection, Licensing, And Quality Systems.
Served As An Inspector For 8 Years, Followed By 23 Years As Head Of Inspection Department And 2 Years As Head Of Licensing Department. Contributed To The Licensing Of Approximately 75% Of Pharmaceutical, Cosmetics, And Medical Device Manufacturing Facilities In Egypt.
An Experienced Trainer With Extensive Involvement In Delivering And Participating In Professional Training Programs Covering GMP, Regulatory Inspection, And Pharmaceutical Quality Systems.
OUTLINE TOPICS :
- 1. GMP REQUIREMENTS FOR PREMISES : CLEAN AREAS CLASSIFICATION MATERIAL & PERSONNEL FLOW ZONING CONCEPT
- 2. LAYOUT DESIGN PRINCIPLES : LOGICAL FLOW (RAW → FINISHED) SEGREGATION (BETA-LACTAM, STERILE, ETC.) AIRLOCKS & PRESSURE CASCADE.
- 3. ROOM CLASSIFICATION : ISO CLASSES / EU GRADES CLEANROOM CONCEPTS.
- 4. COMMON DESIGN MISTAKES : CROSS CONTAMINATION RISKS POOR MATERIAL FLOW.
- 5. WORKSHOP : DESIGN A TABLET FACILITY LAYOUT.