MODULE 3
Pharma HVAC systems, cleanroom design, and GMP compliance.
OUR TALENT INSTRUCTORS:
DR/ HEBA NOAH
Lead Auditor With Over 20 Years Of Experience In Pharmaceutical Inspection, Quality Systems, And GMP Compliance. Key Contributor To The Establishment Of Quality And Documentation Systems Within The Central Administration Of Pharmaceutical Affairs Inspection Sector.
Recognized As A GMP Expert Following Participation In WHO Inspector Training Programs, With Extensive Experience In Delivering Professional Training On Current GMP Requirements.
Specialized In Cleanroom And HVAC Systems, With Solid Consultancy Experience In Pharmaceutical, Cosmetic, And Medical Device Facilities. Expertise Includes Facility Layout Design, Room Data Sheet Development, HVAC System Evaluation, And Full Project Support From Construction Through To Successful Licensing.
ENG/ KHALID MAGHWERY
Mechatronics Engineer And HVAC Project Engineer With Experience In Designing And Implementing HVAC Systems, And Managing Projects From Planning To Delivery.
Strong Knowledge Of GMP Standards And HVAC Systems In Industrial And Pharmaceutical Environments.
Involved In Preparing Engineering Drawings, Supervising Execution, And Ensuring Performance Quality And Technical Compliance. Skilled In Problem-Solving And Working Within Multidisciplinary Teams To Achieve Efficient Operations.
OUTLINE TOPICS :
- 1. HVAC FUNDAMENTALS AHU COMPONENTS FILTRATION (HEPA)
- 2. GMP REQUIREMENTS DAYS PRESSURE DIFFERENTIALS AIR CHANGES PER HOUR TEMPERATURE & HUMIDITY CONTROL
- 3. CLEANROOM DESIGN AIRFLOW PATTERNS (LAMINAR VS TURBULENT) CONTAINMENT SYSTEMS
- 4. QUALIFICATION & VALIDATION AIRFLOW TESTING PARTICLE COUNTING HEPA INTEGRITY TEST
- 5. MAINTENANCE & REQUALIFICATION PREVENTIVE MAINTENANCE ANNUAL REQUALIFICATION