Bernie R. Silvers serves as a Senior Quality Consultant at PRP Compliance, where he leverages his extensive expertise in building and optimizing FDA-regulated Quality Systems across various challenging and innovative industries. With a proven track record of success, Bernie is passionate about developing quality management...
Bernie R. Silvers serves as a Senior Quality Consultant at PRP Compliance, where he leverages his extensive expertise in building and optimizing FDA-regulated Quality Systems across various challenging and innovative industries. With a proven track record of success, Bernie is passionate about developing quality management systems that not only meet but exceed both internal and external customer expectations. His strategic approach combines visionary thinking with practical implementation, ensuring that organizations can navigate the complexities of compliance while maintaining a focus on quality excellence.
In his current role, Bernie is instrumental in the development and implementation of ISO-compliant quality management systems tailored to the unique needs of clients in the life sciences sector. He prepares teams for successful ISO certification audits, meticulously ensuring adherence to international quality standards. By collaborating closely with cross-functional teams—including R&D, manufacturing, engineering, and regulatory affairs—he aligns product development and manufacturing processes with stringent quality objectives. This collaboration is vital in fostering a culture of quality that permeates all aspects of the organization.
Bernie’s expertise extends to critical areas such as Good Manufacturing Practices (GMP), design control, and change control, making him a valuable asset in the biotechnology and life sciences fields. His proficiency in tools like Trackwise and Laboratory Information Management Systems (LIMS) further enhances his ability to establish robust risk management frameworks and streamline quality processes. As a thought leader in the industry, Bernie is committed to driving continuous improvement and ensuring that quality remains at the forefront of organizational priorities.
