NONCONFORMANCE INVESTIGATIONS IN FDA REGULATED INDUSTRIES
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Bio: 
Tarek Elneil is an experienced professional with a strong background in Continuous Quality Improvement. With over 25 years of expertise, Tarek has served as a change agent, specializing in the development of compliant quality systems within the FDA regulated industries
During his tenure at Baxter Bioscience and Cardinal Health, Tarek successfully managed quality improvement projects, employing Six Sigma and Lean Manufacturing principles to generate substantial cost savings amounting to millions of dollars. His accomplishments include the reorganization and enhancement of sample control processes, as well as the design and implementation of a document control unit that significantly improved assay documentation and equipment utilization in the Quality Control lab.
Tarek's leadership skills shine through in his ability to harmonize and standardize 24 quality systems across three pharmaceutical facilities. By streamlining and aligning quality procedures and practices, Tarek effectively enhanced overall quality outcomes. Recognizing the importance of information systems in compliant quality systems, Tarek developed databases to optimize quality information systems in project management and Quality Control.
In addition, Tarek excels in managing Corrective and Preventive Action (CAPA) systems, utilizing problem-solving tools to identify root causes and implement effective improvement solutions. He also played a pivotal role in training employees on Continuous Improvement, Lean Manufacturing, and problem-solving methodologies.
Tarek's contributions extend beyond the pharmaceutical industry, as he has assisted nutraceutical companies in complying with and implementing the new FDA Part 111 regulations.
Tarek holds an MBA and is a distinguished member of the American Society for Quality, serving as the San Fernando Valley Program Chair. Furthermore, he possesses the Certified Quality Manager/Organizational Excellence (CQMOE) and Six Sigma Engineer Senior certifications, further attesting to his expertise in the field of quality management.
Abstract: Nonconformance investigations play a crucial role in regulated industries, ensuring adherence to quality standards and regulatory requirements. This abstract provides an overview of the key aspects involved in nonconformance investigations within such industries.
Firstly, the concept of a process is introduced, highlighting its significance in achieving consistent outcomes and desired results. Processes are complex systems comprising various components and characteristics, which are examined using heuristics-based approaches. By understanding the components and characteristics of a process, organizations can effectively identify potential areas of nonconformance and take appropriate measures to address them.
Process variations and their causes are explored as well. Variations occur when there are deviations from expected outcomes, and understanding their root causes is crucial for effective nonconformance investigations. By analyzing variations, organizations can identify underlying issues and implement corrective actions to prevent future nonconformances.
Furthermore, this abstract presents various methodologies for process improvement. These methodologies provide structured approaches to enhance processes, thereby reducing nonconformance occurrences. Techniques such as Six Sigma, and Lean are discussed, emphasizing their application in regulated industries. These methodologies enable organizations to systematically identify and eliminate process inefficiencies and improve overall quality performance.
In conclusion, nonconformance investigations in regulated industries involve understanding processes, analyzing their components and characteristics, identifying process variations, and implementing process improvement methodologies. By adopting a proactive approach to nonconformance investigations, organizations can ensure compliance with regulations, enhance product quality, and maintain customer satisfaction.