About the Principals

John Chappell

John has over thirty years of experience in leading and improving quality systems primarily for medical manufacturing companies worldwide. 

Prior to consulting John has fulfilled a broad range of positions within device companies including the functions of Operations, Quality, Engineering and Regulatory and titles that range from the shop floor to Group VP Quality. He has held executive management positions in Quality, Regulatory, Engineering and Manufacturing.   As a consultant John has led Quality System development initiatives in numerous medical device and human tissue companies.

His successes and strengths cover a wide range of organizational change initiatives within global organizations.  These include leading and building successful, self-sustaining quality and regulatory systems, successful turnaround of QSR based quality systems and FDA relationships.  He has successfully led company remediations for a FDA Consent Decree of Injunction and many Warning Letters.   

John has also consulted to organizations in the area of change and organizational leadership, making significant improvements to an organization's systems and culture.   He has worked with management and top executives in assessment and strategic planning for continuous improvement.

John has a bachelor's degree in mathematics and a master's degree in business administration.

Certifications:

• RAC (US) - US Regulatory Affairs Certified, by Regulatory Affairs Professionals Society (RAPS).

• RAC (EU) - European Regulatory Affairs Certified, by Regulatory Affairs Professionals Society.

• CBA - Certified Biomedical Auditor for American Society for Quality (ASQ).

Professional Affiliations   

• RAPS - Regulatory Affairs Professionals Society

• RMRAS - Rocky Mountain Regulatory Affairs Society (Current Board Member, President 2006, 2007)

• ASQ - American Society of Quality

Benita Chappell

Benita has over thirty years of experience in regulatory affairs, regulatory compliance, and quality systems development primarily in medical devices such as LASER-containing medical devices, in vitro diagnostics, active implantable devices, biological products, and blood products.

Benita has a wealth of experience in bringing new or changed products into the marketplace in better-than-average time frames.   She has developed and implemented successful submissions strategies that have resulted in turnaround times that consistently exceed industry standards.

Additionally, Benita has led, or been an integral member of, compliance turn-a-round teams that have resulted in the successful resolution of FDA enforcement actions.

Throughout her career, Benita has worked closely with the Food and Drug Administration, both at the local levels and at the national level and developed strong credibility with Agency personnel.  She has been a speaker at numerous conferences on regulatory affairs, regulatory compliance, and quality systems development. 

Among her successes, Benita has developed strong, practical and sustainable quality systems that meet regulatory requirements.  She licensed the first HIV-1, p-24 antigen test for the detection of the virus that causes AIDS.

Benita brings solid experience, a history of success, and practicality to the business of regulatory affairs, compliance, and system development.

Benita has a bachelor’s degree in chemistry and master’s level coursework in health law. 

Certifications

• RAC (US) - US Regulatory Affairs Certified, by Regulatory Affairs Professionals Society (RAPS)
  

• CBA - Certified Biomedical Auditor for American Society for Quality (ASQ)
  

Professional Affiliations    

• RAPS - Regulatory Affairs Professionals Society

• RMRAS - Rocky Mountain Regulatory Affairs Society
  

• ASQ - American Society of Quality