A Lifecycle Approach To Process Validation.

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.

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.

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.

An Experienced Trainer With Extensive Involvement In Delivering And Participating In Professional Training Programs Covering GMP, Regulatory Inspection, And Pharmaceutical Quality Systems.