Mustafa Abdallah

Mr. Abdallah has 20+ years of extensive experience in Quality Management Systems, IT Systems & Computer Systems Validation all in a regulated environment, working within a broad array of Life Sciences organizations. With expertise encompassing both drug sponsor and solution provider considerations Mr. Abdallah is uniquely qualified to tackle the complex challenges which form the foundation of today’s global supply chain and information management systems. Mr. Abdallah has specific experience including creation of phase-appropriate Quality Management Systems (QMS), managing the GLP-GMP and GTP-GMP transition, leading and managing 483 FDA Observation/Warning Letter remediation work, external regulatory audit program design and management including performing GxP audits in various domains. He has extensive experience in the design and deployment of GxP information systems including information master planning, software development life cycle (SDLC) management systems and GxP IT infrastructure creation. These systems are often the backbone of today’s cyber-supply chain and expertise in these systems is essential to meet the regulatory compliance requirements of today’s global marketplace. He is highly experienced with many GxP information systems implementations, including ERP, LIMS, ELN, eQMS, EDMS, MES, in either capacity of project management, validation lead, compliance oversight and even end user support. All have been successfully implemented or remediated to meet business requirements and the associated regulated requirements such as 21CFR 210/211,600, 820, 1271and Part 11 applicability, as well as, SOX 302/404 and ISO 270001.