Professional Overview

Mohammed Q. is a distinguished FDA Regulatory Compliance Expert and GMP Lead Auditor with over a decade of dedicated experience guiding pharmaceutical, biotechnology, and medical device organizations through global quality and regulatory standards. With a track record of leading more than 100+ comprehensive GMP and GSDP audits, Mohammed assists life sciences enterprises in establishing audit-ready quality management systems, remediating critical regulatory findings, and navigating complex market compliance frameworks across the US FDA, EMA, WHO, and PIC/S.

They specialize in executing comprehensive mock inspections, gap assessments, and risk-based Quality Management Systems (QMS) aligned with ICH Q9(R1) and ISO 14971 principles. Their multidisciplinary consulting spans commercial manufacturing oversight, data integrity governance under 21 CFR Part 11, Computer System Validation (CSV), and medical device regulatory readiness under 21 CFR Part 820 (QSR) and ISO 13485.

---

Core Specializations & Capabilities

• GMP & GSDP Auditing: Leading 100+ on-site and remote vendor audits, contract manufacturing (CMO) evaluations, and facility assessments conforming to US FDA 21 CFR 210/211, EU GMP Annexes, and WHO Technical Report Series (TRS).
• Inspection Readiness & Mock Audits: Conducting pre-inspection gap analyses, designing audit defense strategies, and orchestrating comprehensive CAPA remediation roadmaps to preempt 483s and Warning Letters.
• Quality Risk Management (QRM): Designing and deploying robust risk management architectures based on ICH Q9(R1) and ISO 14971 to systematically identify, evaluate, and mitigate manufacturing and documentation risks.
• Medical Device QMS Compliance: End-to-end quality system optimization and audit preparation under FDA 21 CFR Part 820 (Quality System Regulation / QMSR) and ISO 13485:2016.
• Data Integrity & CSV Governance: Evaluating computerized systems, validating electronic batch records, and ensuring ALCOA+ compliance under FDA 21 CFR Part 11 and EU GMP Annex 11.

---

---