CSV and data integrity
GAMP 5 lifecycle strategy, 21 CFR Part 11, Annex 11, URS, risk assessment, IQ/OQ/PQ, RTM, audit trails and validation closure.
Founder profile
Mohammad Awawdeh
Founder and Managing Director, PHARPRO
Pharmaceutical compliance consultant with more than seven years of hands-on validation experience, focused on computerized system validation, quality assurance, CQV, GMP training and responsible digital validation.
Professional focus
Connecting regulatory requirements to evidence teams can use
Mohammad leads PHARPRO’s client scoping and technical delivery across the pharmaceutical validation lifecycle. His work centres on converting regulatory expectations into controlled, risk-based systems: defining intended use, identifying critical functions, writing and executing proportionate qualification activities, maintaining requirements traceability and ensuring the final package can be understood by both the client’s quality unit and an inspector.
He works with pharmaceutical manufacturers, distributors and regulated technology teams across MENA through on-site, remote and hybrid engagements. Final quality decisions and approvals remain with the regulated company; PHARPRO’s role is to provide independent analysis, practical controls and defensible documentation.
Areas of expertise
Specialist coverage across quality, engineering and digital validation
QA and inspection readiness
GMP gap assessments, SOP systems, CAPA, deviations, data-integrity remediation and evidence preparation for authority inspections.
CQV and thermal mapping
Qualification planning and evidence for facilities, utilities, equipment, HVAC, warehouses, cold rooms and controlled environments.
Practical GMP training
Instructor-led training in English and Arabic using real documentation examples, exercises and decisions from regulated projects.
Digital validation
Responsible AI-assisted documentation, human review, role-based approval and traceability through PHARPRO DVS.
MENA delivery
Regional project experience and regulatory alignment for Jordan, UAE, Saudi Arabia, Egypt and other MENA markets.
Selected guidance
Technical articles written and reviewed by Mohammad
These guides are educational and should be applied through the regulated company’s approved quality system and product-specific risk assessment.
EU GMP Annex 11 Compliance ChecklistControls for computerised systems, suppliers, audit trails and lifecycle governance.GAMP 5 Second EditionPractical implications for critical thinking and risk-based validation.Cold Room Thermal Mapping GuideStudy design, sensor placement, challenge conditions and acceptance evidence.GMP Gap Assessment GuideHow to scope findings, prioritise remediation and prepare defensible CAPA.How to Write a URSClear, testable requirements for regulated computerised systems.Pharmaceutical Inspection ReadinessBuilding a sustainable readiness programme rather than a last-minute exercise.
Need an independent view of your compliance challenge?
Share the project, system or inspection priority. Mohammad normally responds within one business day.
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