About EduQuest:

A Global Team of FDA Compliance Experts,headquartered near Washington, DC

 

EduQuest was founded in October 1995 by former FDA investigators.  Since that time, our staff has grown to include additional former FDA personnel as well as experienced technical, quality, and compliance experts from the regulated industries.  The officers and employees of EduQuest thus offer a comprehensive knowledge of FDA and quality auditing procedures and practices and a unique awareness of regulatory enforcement policies and activities. We believe that tremendous synergy comes from having experienced, senior level personnel from both FDA and the industry. Our combined experience also gives us a broad and detailed understanding of the complex business and compliance challenges faced by today’s regulated companies. 

 

Led by Martin Browning, co-author of the original Part 11 regulation and contributor to the medical device Quality System Regulation (QSR)

 

The EduQuest team is led by Martin Browning, the company’s President and co-founder.  Martin spent 22 years with FDA as a local, national, and international expert investigator, and then as a Special Assistant to the Associate Commissioner for Regulatory Affairs. While with FDA, he also served as the Vice Chair of the agency’s Electronic Record and Signature Working Group, which drafted the 21 CFR Part 11 regulations. Martin also served as the Chair of the U.S. Government ISO-9000 Committee; on the Global Harmonization Task Force; and on the committee that developed the Good Manufacturing Practice regulations for medical devices, otherwise known as the Quality System Regulation (QSR). 

 

Supported by a team that has conducted inspections throughout the world, developed FDA inspection techniques and SOPs, and trained FDA and Health Canada investigators

 

The relatively brief history of EduQuest, however, does not fully reflect our extensive experience in addressing regulatory compliance, validation, and related technical issues. During their careers at FDA, EduQuest professionals –

 

  • Participated in developing many of the enforcement policies and inspectional procedures currently used by the agency;

  • Developed and presented the training courses that FDA uses to train investigators in GMPs, computerized system validation, process validation, and auditing; and

  • Conducted, supervised, and/or coordinated thousands of FDA inspections and audits involving FDA-regulated industries at every stage of research, development, and marketing. 

 Many of the FDA inspections performed by our professionals involved findings of substantial violations and resulted in further administrative and legal enforcement actions by the U.S. government, including injunctions, product seizures, and criminal prosecutions. This inspectional experience gives us first-hand knowledge of some of the best and worst compliance efforts across the regulated industries, as well as the practical risks and consequences of non-compliance. 

 

Enhanced by senior executives and quality managers from world-class pharmaceutical and medical device companies

 

It is important to recognize that our staff includes more than former FDA investigators and reviewers. Several of our employees have decades of experience in achieving or assessing compliance as career industry professionals, with expertise in quality, compliance, manufacturing, clinical research, regulatory enforcement, adverse event reporting, validation, and software development. This gives us the ability to provide our clients the combined expertise of knowledgeable professionals who have directly experienced both sides of the regulatory compliance and enforcement environment.

Click here for more information on the professional experience and qualifications of EduQuest's expert staff.

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