Mike Harner serves as the Director of FDA & DOT Compliance at Rotech Healthcare Inc, where he leverages over four decades of experience in the Home Health Care and Durable Medical Equipment sectors. Since 1997, Mike has been instrumental in ensuring compliance with current Good...
Mike Harner serves as the Director of FDA & DOT Compliance at Rotech Healthcare Inc, where he leverages over four decades of experience in the Home Health Care and Durable Medical Equipment sectors. Since 1997, Mike has been instrumental in ensuring compliance with current Good Manufacturing Practices (cGMP) for the production of Liquid and Gaseous Medical Oxygen, a critical component in patient care. His extensive background has equipped him with a deep understanding of regulatory requirements and the intricacies of maintaining high standards in healthcare management.
In his current role, Mike oversees the auditing process for all FDA and DOT registered Oxygen Manufacturing Facilities under Rotech Healthcare Inc. He is dedicated to ensuring that these facilities adhere to both state and federal regulations, as well as company policies and procedures. This involves not only conducting thorough audits but also developing and implementing Standard Operating Procedures (SOPs) that enhance operational efficiency while maintaining compliance. His expertise in regulatory affairs is complemented by his skills in training and leadership, allowing him to effectively guide teams in navigating complex compliance landscapes.
Mike's commitment to quality and safety in healthcare is evident in his proactive approach to compliance management. He collaborates closely with cross-functional teams to foster a culture of continuous improvement, ensuring that Rotech Healthcare remains at the forefront of industry standards. His strategic vision and hands-on experience make him a valuable asset in the ever-evolving landscape of healthcare regulations, where patient safety and compliance are paramount.
