Mohammed Abdelnaiem Salem Q.

FDA Regulatory Compliance Expert | QMS & Risk Management A top-performing FDA regulatory compliance expert specializing in GMP auditing and quality management systems in the pharmaceutical and biotechnology sectors. Successfully led audits ensuring compliance with FDA, EMA, and ISO standards and optimized QMS frameworks to enhance operational efficiency . Leverages expertise in risk management, regulatory strategies, and compliance training to mitigate risks and elevate organizational standards. A skilled FDA regulatory compliance expert specializing in auditing, quality management, and risk assessment in the pharmaceutical and biotechnology sectors. Proficient in regulatory strategies, quality risk management, and compliance training. Leverages expertise in FDA regulations, quality assurance, and project management to mitigate risks and elevate organizational standards Core skills include Quality Assurance, Regulatory Compliance, and Project Management, applied through rigorous audits and strategic improvements With over a decade of experience in the pharmaceutical, biotechnology, and medical device industries, I specialize in GMP compliance, regulatory strategy, and quality system optimization. I have successfully guided organizations through FDA, EMA, WHO, and ISO compliance, ensuring adherence to global regulatory standards and best practices. Expertise & Achievements: ✅ Regulatory Compliance & Auditing: - Conducted 100+ GMP/GSDP audits, assessing compliance with FDA 21 CFR, EU GMP, WHO TRS, PIC/S, and ISO 13485. - Led mock inspections, gap assessments, and remediation strategies to minimize regulatory risks. ✅ Quality Management & Risk-Based Approach: - Implemented ICH Q9(R1)- ISO 14971 aligned Quality Risk Management (QRM) frameworks, - Applying the best tools selection methodologies to optimize compliance, reduce deviations, and enhance operational efficiency. - Medical Device Compliance: Specialized in FDA QSR (21 CFR Part 820), ISO 13485, - Training & Industry Leadership: - Recognized LinkedIn Top Voice for contributions to GMP, Quality Systems, and Risk Management. - Led global training programs, mentoring professionals on audit preparedness, CAPA, and regulatory updates. - Ensuring robust QMS and data integrity across regulated environments, - 21 CFR Part 11 (electronic records and signatures), and Computer System Validation (CSV) . What I Offer: ✔ GMP/GSDP & FDA Regulatory Consulting (Mock Inspections, Compliance Roadmaps, CAPA Remediation) ✔ Medical Device & Pharmaceutical QMS Optimization (ISO 13485, Part 820, Risk Management) ✔ Comprehensive Vendor Audits & Supply Chain Compliance ✔ Data Integrity & Quality Risk Management Strategies ✔ Regulatory Affairs & Market Access Consulting (FDA, EMA, WHO, PIC/S, ISO) 📌 Let’s Connect: If you're looking for expert guidance on regulatory compliance, QMS automation, or GMP inspection readiness, let’s discuss how I can support your business.