Johna Carufel
Johna Carufel, CCEP, RAC
Johna Carufel is a Senior Associate with over two decades of experience in the life sciences industry, with expertise ranging from healthcare compliance for pharmaceutical manufacturers, compliance risk assessments, compliance program development and assessment, independent review organization, compliance board expert, field force and speaker program monitoring, education and training development, and regulatory compliance for medical device manufacturers.
Johna supports healthcare life sciences clients who are under a Corporate Integrity Agreement (CIA) and companies proactively reviewing their compliance programs. While at Epsilon Life Sciences, Johna has assisted various pharmaceutical manufacturers and provider organizations in the review and development of their risk assessment process and compliance programs, including CIA prescribed board advisory services and organization-wide compliance effectiveness reviews; leveraging Office of Inspector General (OIG) guidance and Federal regulations to report on the current operative state as well as future sustainability. Johna also routinely assists organizations in the role of an Independent Review Organization (IRO), encompassing all aspects of both systems and transactions reviews, including engagement of physicians, sales incentive compensation, sample distribution plans, and medical information requests. Johna has assisted a very large provider organization with the development and implementation of a compliance program in response to a Department of Justice (DOJ) investigation, including the development of a work plan and leading the field work resulting in the implementation of all foundational elements required for an effective compliance program.
Johna is a Certified Compliance and Ethics Professional (CCEP) by the Society of Corporate Compliance and Ethics and has Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professionals Society.