Mohamed Mestari is an Engagement Leader at USDM Life Sciences.
Brian is an experienced professional with a 21 years in the life sciences industry. He specializes in risk-based design, development, QA, Validation and Verification, GxP compliance and quality audits of Medical Device softwar, computerized and automated systems for Product Development, Production, Quality Management, Supply Chain, IT infrasturcutre and Business Intelligence operations.
Mohamed's skills include:
- Development and implementation of quality management processes, software development life cycle process, QA and compliance governance based on metrics, design controls, risk management, system robustness testing, change management, infrastructure support systems, complaint handling, corrective and preventive action, servicing, quality auditing and training.
- Assessing information security risk, including risk modeling, assessing risk factors, relationships among the factors and performing asset impact-oriented analyses. Qualitative assessment of vulnerabilities not only within information systems but also in organizational governance and external structures. Implementation and maintenance of risk controls.
- Masters of Science graduate studies focused on Information Systems and Mobile Security.
- Interpretation and implementation of QSRs/cGMPs (21 CFR Part 11/210/211/820 and Annex 11).
- Implementation of industry standards (ISO 13485, 14971, 29147, 80002, GAMP 5, IEC 60601, 61025, 62304, IEEE 1012 and CISSP guide).