Roger Rand's career includes 27 years in FDA regulated industries (22 in medical devices, 29 years as an ASQ CQE) in a progressive range of various Quality and Regulatory management positions, Because of this broad background he has the flexibility to fill many roles, but his primary experience has been in Quality Assurance and FDA compliance. He has the experience to quickly discover gaps in systems and offer hands on help with effective and efficient corrective action. Prior to becoming a consultant, as Corporate Global Quality Systems Director he focused on FDA compliance for medical device plants around the world to avoid problems with the FDA. In his consulting career his focus has been primarily on remediation, and FDA reinspection readiness to clear FDA 483 observations and warning letters - now in five different FDA districts along with foreign locations. So far he has a perfect record of success with FDA reinspections. Roger’s leadership to successfully bring firms into compliance was accomplished by developing a system that the organization could consistently support after Roger had completed the remediation project. Roger has written all major SOP’s required to support compliance to the FDA QSR. He pragmatically tailored them to the individual client. In principle, most of the required SOP’s have been reviewed and accepted by seven different FDA Investigators in five different FDA districts in their follow up inspections. He has the experience and is willing and able to carry out all of the functions required to comply with FDA and international medical device requirements. Roger has a demonstrated management and leadership ability. He has the experience and capability of taking a pragmatic, business approach in directing a very effective and efficient management team. He enjoys, not just pointing out what needs to be corrected, but helping a firm to do whatever it takes to get the job done. rrand@charter.net828-638-9735 cellSpecialties: medical device quality / regulatory compliance