In 2010, Lori obtained the U.S. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Certified Quality Auditor (CQA) certification from the American Society for Quality (ASQ).

U.S. Regulatory Affairs Certification (RAC)

RAC Logo

Regulatory Affairs Certification, known as the RAC, is the only certification specifically for regulatory professionals in the healthcare product sector. The RAC credential is a professional distinction that denotes commitment to excellence, pursuit of knowledge and career advancement. RAC-credentialed professionals are among the current and rising leaders in the regulatory profession. They work in all parts of the world and in many settings, including industry, government and academic organizations.

Link to Regulatory Affairs Professionals Society

Certified Quality Auditor (CQA)

ASQ Logo

The Certified Quality Auditor is a professional who understands the standards and principles of auditing and the auditing techniques of examining, questioning, evaluating and reporting to determine a quality system's adequacy and deficiencies. The Certified Quality Auditor analyzes all elements of a quality system and judges its degree of adherence to the criteria of industrial management and quality evaluation and control systems.

Link to the American Society for Quality

Principal Auditor (RABQSA)

The Qualification Based Quality Management System (QMS) program has been accredited under ISO17024:2003. To ensure continued maximum effectiveness, a quality management system requires regular performance assessment. This is best achieved by using competent auditors. The benefits being:

  • Provides international recognition for professionals managing quality management systems in accordance with ISO9001:2008 & ISO19011:2011.  This also includes ISO13485:2003.
  • Provides proof of competence to effectively manage quality issues via extensive examination of knowledge, work experience and competence to audit.

This qualification based certification meets and exceeds the qualification guidelines described in ISO 19011:2002.

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