Maurice Miller is a distinguished Principal and co-founder of Gwen Ryan Solutions, LLC, where he leverages over two decades of expertise in the medical device and pharmaceutical sectors. His extensive background encompasses quality, regulatory, and manufacturing operations, with a particular focus on product development and...
Maurice Miller is a distinguished Principal and co-founder of Gwen Ryan Solutions, LLC, where he leverages over two decades of expertise in the medical device and pharmaceutical sectors. His extensive background encompasses quality, regulatory, and manufacturing operations, with a particular focus on product development and successful product launches. At Gwen Ryan Solutions, Maurice plays a pivotal role in guiding global companies through the complexities of compliance and quality systems remediation, ensuring they meet stringent regulatory standards.
Currently, Maurice is spearheading key projects that involve conducting comprehensive gap assessments for Quality Management Systems (QMS) in accordance with ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and both the EU Medical Device Directive and Regulation. His proficiency in these areas not only helps clients navigate the intricacies of regulatory compliance but also enhances their operational efficiencies. Maurice's strategic insights have been instrumental in advising organizations on the development and implementation of robust quality compliance frameworks, which are critical for maintaining GxP standards and ensuring patient safety.
In addition to his consulting work, Maurice specializes in critical areas such as Corrective and Preventive Actions (CAPA), validation processes, and root cause analysis. His deep understanding of 21 CFR Part 11 requirements and his experience with biopharmaceuticals further bolster his ability to provide tailored solutions that address the unique challenges faced by life sciences companies. Maurice’s commitment to excellence and his strategic approach to quality systems make him a trusted partner for organizations striving to achieve regulatory compliance and operational excellence in an ever-evolving industry landscape.
